ExpoRecalls & reported problems across all models

Boston Scientific Corporation · 47 models in the FDA device registry

Data updated Oct 16, 2026 from official FDA records · Editorial policy

48 open recalls name at least one Expo model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.

Adverse event reports: 38
Deaths reported: 0
Injuries reported: 9
Recalls: 48

We found 47 models of Expo by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 38 adverse event reports in the FDA's MAUDE database, received between Mar 18, 2019 and Jan 27, 2025 — classified as 9 injuries, 29 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (15 reports).

48 FDA recall records name at least one of these models by its device identifier, 48 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Reports received per month, all models

Last 36 months. The most recent month may be incomplete.

Expo recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

Mar 21, 2024Open, Classified
An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.
Z-1685-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Mar 21, 2024Open, Classified
An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.
Z-1684-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Mar 21, 2024Open, Classified
An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.
Z-1683-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Mar 21, 2024Open, Classified
An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.
Z-1682-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Mar 21, 2024Open, Classified
An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.
Z-1681-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Mar 21, 2024Open, Classified
An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.
Z-1680-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Mar 21, 2024Open, Classified
An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.
Z-1679-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Mar 21, 2024Open, Classified
An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.
Z-1678-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Mar 21, 2024Open, Classified
An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.
Z-1677-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Mar 21, 2024Open, Classified
An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.
Z-1676-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Mar 21, 2024Open, Classified
An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.
Z-1675-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Mar 21, 2024Open, Classified
An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.
Z-1674-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Mar 21, 2024Open, Classified
An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.
Z-1673-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Mar 21, 2024Open, Classified
An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.
Z-1672-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Mar 21, 2024Open, Classified
An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.
Z-1671-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Mar 21, 2024Open, Classified
An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.
Z-1670-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Mar 21, 2024Open, Classified
An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.
Z-1669-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Mar 21, 2024Open, Classified
An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.
Z-1668-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Mar 21, 2024Open, Classified
An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.
Z-1667-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Mar 21, 2024Open, Classified
An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.
Z-1666-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Mar 21, 2024Open, Classified
An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.
Z-1665-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Mar 21, 2024Open, Classified
An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.
Z-1664-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Mar 21, 2024Open, Classified
An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.
Z-1663-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Mar 21, 2024Open, Classified
An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.
Z-1662-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Mar 21, 2024Open, Classified
An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.
Z-1661-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Mar 21, 2024Open, Classified
An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.
Z-1660-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Mar 21, 2024Open, Classified
An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.
Z-1659-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Mar 21, 2024Open, Classified
An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.
Z-1658-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Mar 21, 2024Open, Classified
An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.
Z-1657-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Mar 21, 2024Open, Classified
An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.
Z-1656-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

…and 18 older recalls, listed on each model's page.

Most reported Expo problems

Device problems

Device Contamination with Chemical or Other Material15
Difficult to Advance13
Detachment of Device or Device Component7
Adverse Event Without Identified Device or Use Problem5
Device Contaminated During Manufacture or Shipping5
Entrapment of Device4
Difficult to Remove2
Fracture2

Patient problems

No Clinical Signs, Symptoms or Conditions27
Vascular Dissection4
Foreign Body In Patient2
No Patient Involvement2
Fistula1
No Consequences Or Impact To Patient1
No Known Impact Or Consequence To Patient1
Perforation of Vessels1

Expo models

47 models, most reported first. Each model has its own page with its reports, recalls and device details.

Expo™ H749085263011
CATHETER, INTRAVASCULAR, DIAGNOSTIC
2 recalls3 reports
Expo™ H74908526501
CATHETER, INTRAVASCULAR, DIAGNOSTIC
2 recalls1 report
Expo™ H74908526511
CATHETER, INTRAVASCULAR, DIAGNOSTIC
2 recalls0 reports
Expo™ H74908526031
CATHETER, INTRAVASCULAR, DIAGNOSTIC
2 recalls0 reports
Expo™ H749085263001
CATHETER, INTRAVASCULAR, DIAGNOSTIC
2 recalls0 reports
Expo™ H74908526211
CATHETER, INTRAVASCULAR, DIAGNOSTIC
1 recall11 reports
Expo™ H74908526021
CATHETER, INTRAVASCULAR, DIAGNOSTIC
1 recall8 reports
Expo™ H74908526961
CATHETER, INTRAVASCULAR, DIAGNOSTIC
1 recall6 reports
Expo™ H74908526221
CATHETER, INTRAVASCULAR, DIAGNOSTIC
1 recall1 report
Expo™ H74908526891
CATHETER, INTRAVASCULAR, DIAGNOSTIC
1 recall1 report
Expo™ H749085263021
CATHETER, INTRAVASCULAR, DIAGNOSTIC
1 recall1 report
Expo™ H74908526051
CATHETER, INTRAVASCULAR, DIAGNOSTIC
1 recall0 reports
Expo™ H749085261801
CATHETER, INTRAVASCULAR, DIAGNOSTIC
1 recall0 reports
Expo™ H749085262021
CATHETER, INTRAVASCULAR, DIAGNOSTIC
1 recall0 reports
Expo™ H749085262031
CATHETER, INTRAVASCULAR, DIAGNOSTIC
1 recall0 reports
Expo™ H74908526011
CATHETER, INTRAVASCULAR, DIAGNOSTIC
1 recall0 reports
Expo™ H74908526041
CATHETER, INTRAVASCULAR, DIAGNOSTIC
1 recall0 reports
Expo™ H749085261001
CATHETER, INTRAVASCULAR, DIAGNOSTIC
1 recall0 reports
Expo™ H749085261711
CATHETER, INTRAVASCULAR, DIAGNOSTIC
1 recall0 reports
Expo™ H749085261901
CATHETER, INTRAVASCULAR, DIAGNOSTIC
1 recall0 reports
Expo™ H749085261951
CATHETER, INTRAVASCULAR, DIAGNOSTIC
1 recall0 reports
Expo™ H749085262011
CATHETER, INTRAVASCULAR, DIAGNOSTIC
1 recall0 reports
Expo™ H749085262201
CATHETER, INTRAVASCULAR, DIAGNOSTIC
1 recall0 reports
Expo™ H749085262251
CATHETER, INTRAVASCULAR, DIAGNOSTIC
1 recall0 reports
Expo™ H749085262301
CATHETER, INTRAVASCULAR, DIAGNOSTIC
1 recall0 reports
Expo™ H74908526231
CATHETER, INTRAVASCULAR, DIAGNOSTIC
1 recall0 reports
Expo™ H749085262351
CATHETER, INTRAVASCULAR, DIAGNOSTIC
1 recall0 reports
Expo™ H749085262401
CATHETER, INTRAVASCULAR, DIAGNOSTIC
1 recall0 reports
Expo™ H74908526241
CATHETER, INTRAVASCULAR, DIAGNOSTIC
1 recall0 reports
Expo™ H74908526841
CATHETER, INTRAVASCULAR, DIAGNOSTIC
1 recall0 reports
Expo™ H74908526861
CATHETER, INTRAVASCULAR, DIAGNOSTIC
1 recall0 reports
Expo™ H74908526981
CATHETER, INTRAVASCULAR, DIAGNOSTIC
1 recall0 reports
Expo™ H7490852620A1
CATHETER, INTRAVASCULAR, DIAGNOSTIC
1 recall0 reports
Expo™ H749085265001
CATHETER, INTRAVASCULAR, DIAGNOSTIC
1 recall0 reports
Expo™ H749085265021
CATHETER, INTRAVASCULAR, DIAGNOSTIC
1 recall0 reports
Expo™ H74908526572A1
CATHETER, INTRAVASCULAR, DIAGNOSTIC
1 recall0 reports
Expo™ H74908526573A1
CATHETER, INTRAVASCULAR, DIAGNOSTIC
1 recall0 reports
Expo™ H74908526574A1
CATHETER, INTRAVASCULAR, DIAGNOSTIC
1 recall0 reports
Expo™ H74908526575A1
CATHETER, INTRAVASCULAR, DIAGNOSTIC
1 recall0 reports
Expo™ H749085262501
CATHETER, INTRAVASCULAR, DIAGNOSTIC
1 recall0 reports
Expo™ H749085262511
CATHETER, INTRAVASCULAR, DIAGNOSTIC
1 recall0 reports
Expo™ H749085262521
CATHETER, INTRAVASCULAR, DIAGNOSTIC
1 recall0 reports
Expo™ H749085262531
CATHETER, INTRAVASCULAR, DIAGNOSTIC
1 recall0 reports
Expo™ H74908526401
CATHETER, INTRAVASCULAR, DIAGNOSTIC
2 reports
Expo™ H749086412011
CATHETER, INTRAVASCULAR, DIAGNOSTIC
2 reports
Expo™ H74908526411
CATHETER, INTRAVASCULAR, DIAGNOSTIC
1 report
Expo™ H74908641411
CATHETER, INTRAVASCULAR, DIAGNOSTIC
1 report

Recent Expo adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

InjuryJan 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THERE WAS A THROMBUS PRESENT. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS BEING PERFORMED. A WATCHMAN FXD CURVE ACCESS SYSTEM (WAS) AND A 24MM WATCHMAN FLX PRO LAA CLOSURE DEVICE & DELIVERY SYSTEM (WDS) WERE SELECTED TO BE USED. 10,00 UNITS OF HEPARIN WAS GIVEN PRIOR TO THE TRANSEPTAL PUNCTURE. THE TRANSSEPTAL PUNCTURE WAS THEN COMPLETED AND THE PHYSICIAN POSITIONED THE WAS IN THE LAA OF THE PATIENT. A SECOND DOSE OF 10,000 UNITS OF HEPARIN WAS GIVEN AFTER THE TRANSSEPTAL PUNCTURE. THE WDS WAS PREPARED, AND THE EXPO PIGTAIL CATHETER WAS REMOVED BUT CAME OUT WITH A THROMBUS PRESENT. THE PHYSICIAN REMOVED THE WAS AND ALL PRODUCTS FROM THE PATIENT. AN ADDITIONAL 10,000 UNITS OF HEPARIN WAS GIVEN TO THE PATIENT, AND THE PROCEDURE WAS CONTINUED WITH ALL NEW PRODUCTS. THE PROCEDURE WAS COMPLETED WITH THE CLOSURE DEVICE IMPLANTED IN THE LAA OF THE PATIENT. THE PATIENT DID NOT EXPERIENCE ANY COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT WILL BE OBSERVED FOR SIX (6) HOURS POST PROCEDURE AND THEN BE DISCHARGED HOME.
Patient problems: Thrombosis/Thrombus
MAUDE report 21242082 ↗
MalfunctionDec 3, 2024Break; Break
IT WAS REPORTED THAT A DEVICE FRACTURE OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE AORTIC ROOT. A 110CM 5F EXPO GUIDE CATHETER WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE PIGTAIL CATHETER BROKE NEAR THE TIP WHILE TRYING TO ADVANCE ACROSS AORTIC VALVE. THE DEVICE WAS PULLED OUT THROUGH THE SHEATH AND THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT COMPLICATIONS REPORTED POST PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20835915 ↗
MalfunctionSep 26, 2024Device Contamination with Chemical or Other Material; Adverse Event Without Identified Device or Use Problem; Device Contamination with Chemical or Other Material; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT UNKNOWN MATERIAL CAME OUT OF THE DEVICE. AN EXPO ANGIOGRAPHIC CATHETER WAS SELECTED FOR USE. DURING THE PROCEDURE, A TUBULAR MATERIAL OR UNKNOWN FOREIGN BODY WAS NOTED AND REMOVED FROM CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20315053 ↗
MalfunctionApr 29, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE CATHETER SHAFT BROKE. AN EXPO GUIDE CATHETER WAS SELECTED FOR USE. DURING THE PROCEDURE, THE END PIECE IS BREAKING LOOSE. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19209852 ↗
MalfunctionApr 29, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE CATHETER SHAFT BROKE. AN EXPO GUIDE CATHETER WAS SELECTED FOR USE. DURING THE PROCEDURE, THE END PIECE IS BREAKING LOOSE. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19209842 ↗
MalfunctionApr 29, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE CATHETER SHAFT BROKE. AN EXPO GUIDE CATHETER WAS SELECTED FOR USE. DURING THE PROCEDURE, THE END PIECE IS BREAKING LOOSE. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19209836 ↗
MalfunctionApr 4, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT A SMALL PIECE OF PLASTIC WAS PUSHED OUT OF THE TIP OF THE DEVICE. AN EXPO CATHETER-DIAGNOSTIC WAS SELECTED FOR USE. DURING TESTING OF THE DEVICE, OUTSIDE THE PATIENT, A VERY HIGH RESISTANCE UPON INSERTING THE GUIDEWIRE INTO THE DEVICE. WHEN APPLYING A STRONG PRESSURE, A SMALL PIECE OF PLASTIC WAS PUSHED OUT OF THE TIP FROM INSIDE THE CATHETER AND WAS BENT. THE PROCEDURE WAS COMPLETED WITHOUT PATIENT COMPLICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19041937 ↗
MalfunctionApr 3, 2024Difficult to Advance; Device Contamination with Chemical or Other Material; Difficult to Advance; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT A FOREIGN MATERIAL WAS PRESENT IN THE DEVICE. AN EXPO DIAGNOSTIC CATHETER WAS SELECTED FOR USE. DURING PREPARATION, WHILE PASSING THE WIRE THROUGH THE EXPO CATHETER, A WHITE PIECE CAME OUT FROM CATHETER AND ATTACHED TO DISTAL PORTION OF THE WIRE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19034431 ↗
InjuryApr 1, 2024Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component
IT WAS REPORTED THAT THE CATHETER BROKE OFF IN THE PATIENT AND THEY REQUIRED SURGICAL INTERVENTION TO REMOVE IT. AN EXPO DIAGNOSTIC CATHETER WAS SELECTED FOR USE. DURING THE PROCEDURE, THE CATHETER BROKE OFF IN THE PATIENT AND THEY REQUIRED SURGICAL INTERVENTION TO REMOVE IT. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. IT WAS FURTHER REPORTED THAT THE DISTAL HALF TO TWO THIRDS OF THE SEPARATED CATHETER WERE WHAT WAS STUCK INSIDE THE PATIENT'S ARM JUST ABOVE THE BRACHIAL AREA UP THROUGH THE SUBCLAVIAN ARTERY AREA. THE DEVICE BECAME SO TWISTED BUT IT APPEARS TO HAVE DETACHED UPON ATTEMPTS TO REMOVE IT FROM THE BODY. AFTER WHICH IT BROKE OFF AND HAD TO BE SURGICALLY REMOVED.
Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions
MAUDE report 19015890 ↗
MalfunctionFeb 20, 2024Difficult to Advance; Device Contamination with Chemical or Other Material; Difficult to Advance; Device Contamination with Chemical or Other Material
IT WAS REPORTED VIA MEDWATCH # MW5150065 THAT A FOREIGN MATERIAL WAS PRESENT ON THE DEVICE. AN EXPO DIAGNOSTIC CATHETER WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE CATHETER WAS NOT ALLOWING THE WIRE TO PASS THROUGH AND THERE WAS A PIECE OF PLASTIC ON THE WIRE WHEN REMOVED FROM THE PACKAGE. NO PATIENT COMPLICATIONS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18740611 ↗
MalfunctionFeb 19, 2024Fracture; Difficult to Insert; Difficult to Advance; Material Deformation; Fracture; Difficult to Insert; Difficult to Advance; Material Deformation
IT WAS REPORTED THAT THE DEVICE WAS FRACTURED. A MODEL-5F EXPO MULTIPACK 145 (5PKX3) WAS SELECTED FOR PERCUTANEOUS CORONARY INTERVENTION (PCI). DURING THE PROCEDURE, THE EXPO CATHETER MULTIPACK FOUND TO HAVE A STRICTURE IN THE 'L' CATHETER OF MULTIPLE CATHETERS IN THE PACK WHICH MADE THEM DIFFICULT TO FLUSH AND IMPOSSIBLE TO PASS A WIRE. FURTHERMORE, IT WAS NOTED THAT THE DEVICE WAS FRACTURED. THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT'S BODY AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED AND THE PATIENT WAS STABLE AFTER THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18730450 ↗
MalfunctionFeb 8, 2024Difficult to Advance; Device Contamination with Chemical or Other Material; Difficult to Advance; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT FOREIGN MATERIAL WAS PRESENT IN THE DEVICE. AN EXPO DIAGNOSTIC CATHETER WAS SELECTED FOR USE. DURING THE PROCEDURE, THE CATHETER WAS ADVANCED IN PATIENT. HOWEVER, AN ATTEMPT TO LOAD THE WIRE, THE WIRE WAS NOT SUCCESSFUL DUE TO A WHITE PLASTIC PIECE BEING LODGED IN THE CATHETER. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18667814 ↗
MalfunctionJan 26, 2024Difficult to Advance; Device Contamination with Chemical or Other Material; Difficult to Advance; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT FOREIGN MATERIAL WAS PRESENT IN THE DEVICE. AN EXPO GUIDE CATHETER WAS SELECTED FOR USE. DURING THE PROCEDURE, WHEN THE CATHETER WAS BEING FLUSHED PRIOR TO INSERTION INTO THE PATIENT, A PIECE OF PLASTIC CAME OUT ON THE WIRE BEFORE ENTERING INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18592240 ↗
MalfunctionJan 12, 2024Difficult to Advance; Device Contamination with Chemical or Other Material; Difficult to Advance; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT FOREIGN MATTER WAS PRESENT IN THE DEVICE. AN EXPO GUIDE CATHETER WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE WIRE WAS UNABLE TO ADVANCE THROUGH THE CATHETER. FURTHERMORE, A PIECE OF PLASTIC WAS NOTED INSIDE THE CATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18502504 ↗
MalfunctionJan 12, 2024Difficult to Advance; Device Contamination with Chemical or Other Material; Difficult to Advance; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT FOREIGN MATTER WAS PRESENT IN THE DEVICE. AN EXPO GUIDE CATHETER WAS SELECTED FOR USE. DURING THE PROCEDURE, WHEN THE PHYSICIAN TRIED TO LOAD THE WIRE, IT WAS NOTED THAT THE WIRE WAS UNABLE TO ADVANCE THROUGH THE CATHETER. FURTHERMORE, A PIECE OF PLASTIC WAS NOTED BLOCKING INSIDE THE CATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18502129 ↗

Other Boston Scientific Corporation products

All Boston Scientific Corporation devices →

Sources and updates

Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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