AmplatzRecalls & reported problems across all models
Cook Incorporated · 42 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one Amplatz model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 195
- Deaths reported
- 2
- Injuries reported
- 12
- Recalls
- 1
We found 42 models of Amplatz by Cook Incorporated in the FDA's device registry (GUDID). Together they are named in 195 adverse event reports in the FDA's MAUDE database, received between Oct 12, 2016 and Aug 26, 2026 — classified as 2 deaths, 12 injuries, 181 malfunctions.
The most frequently reported specific device problem is “Material Protrusion/Extrusion” (48 reports).
1 FDA recall record name at least one of these models by its device identifier, 1 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
Amplatz 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.
- Aug 16, 2022Open, Classified
Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compromised.
Z-1824-2022 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported Amplatz problems
Device problems
- Material Protrusion/Extrusion48
- Unraveled Material39
- Device Contaminated During Manufacture or Shipping21
- Break16
- Material Separation16
- Contamination /Decontamination Problem12
- Material Frayed12
- Device Contamination with Chemical or Other Material7
Patient problems
- No Clinical Signs, Symptoms or Conditions75
- No Patient Involvement38
- No Known Impact Or Consequence To Patient37
- No Consequences Or Impact To Patient30
- Cardiac Perforation4
- Device Embedded In Tissue or Plaque4
- Foreign Body In Patient4
- Insufficient Information4
Amplatz models
42 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Amplatz G06801WIRE, GUIDE, CATHETER1 recall7 reports
- Amplatz G03460WIRE, GUIDE, CATHETER1 death45 reports
- Amplatz G03562WIRE, GUIDE, CATHETER20 reports
- Amplatz G03565WIRE, GUIDE, CATHETER1 death12 reports
- Amplatz G11684WIRE, GUIDE, CATHETER12 reports
- Amplatz G11674WIRE, GUIDE, CATHETER10 reports
- Amplatz G07515WIRE, GUIDE, CATHETER6 reports
- Amplatz G04001WIRE, GUIDE, CATHETER5 reports
- Amplatz G04003WIRE, GUIDE, CATHETER5 reports
- Amplatz G04237WIRE, GUIDE, CATHETER5 reports
- Amplatz G27032WIRE, GUIDE, CATHETER5 reports
- Amplatz G53560Endoscopic guidewire, gastroenterology-urology5 reports
- Amplatz G09956WIRE, GUIDE, CATHETER4 reports
- Amplatz G11837WIRE, GUIDE, CATHETER4 reports
- Amplatz G53567Endoscopic guidewire, gastroenterology-urology4 reports
- Amplatz G03095WIRE, GUIDE, CATHETER3 reports
- Amplatz G08280WIRE, GUIDE, CATHETER3 reports
- Amplatz G09709STENT, URETERAL3 reports
- Amplatz G10168WIRE, GUIDE, CATHETER3 reports
- Amplatz G27035WIRE, GUIDE, CATHETER3 reports
- Amplatz G28781WIRE, GUIDE, CATHETER3 reports
- Amplatz G53569Endoscopic guidewire, gastroenterology-urology3 reports
- Amplatz G03330WIRE, GUIDE, CATHETER2 reports
- Amplatz G09710STENT, URETERAL2 reports
- Amplatz G09711STENT, URETERAL2 reports
- Amplatz G20320WIRE, GUIDE, CATHETER2 reports
- Amplatz G53566Endoscopic guidewire, gastroenterology-urology2 reports
- Amplatz G03203WIRE, GUIDE, CATHETER1 report
- Amplatz G03540WIRE, GUIDE, CATHETER1 report
- Amplatz G03547WIRE, GUIDE, CATHETER1 report
- Amplatz G03584WIRE, GUIDE, CATHETER1 report
- Amplatz G03750WIRE, GUIDE, CATHETER1 report
- Amplatz G09954WIRE, GUIDE, CATHETER1 report
- Amplatz G11975CATHETER, NEPHROSTOMY1 report
- Amplatz G12232WIRE, GUIDE, CATHETER1 report
- Amplatz G14292DILATOR, URETHRAL1 report
- Amplatz G19854WIRE, GUIDE, CATHETER1 report
- Amplatz G28783WIRE, GUIDE, CATHETER1 report
- Amplatz G53556Endoscopic guidewire, gastroenterology-urology1 report
- Amplatz G53559Endoscopic guidewire, gastroenterology-urology1 report
- Amplatz G53564Endoscopic guidewire, gastroenterology-urology1 report
- Amplatz G53568Endoscopic guidewire, gastroenterology-urology1 report
Recent Amplatz adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionAug 26, 2026Contamination /Decontamination Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50460672 ↗DeathMar 2, 2026Adverse Event Without Identified Device or Use Problem
AS REPORTED TO COOK BY ANOTHER DEVICE MANUFACTURER (ABBOTT), DURING AN UNSPECIFIED PROCEDURE INVOLVING A PATIENT WITH LEFT ATRIAL FLUTTER, A SAFE-T-J AMPLATZ EXTRA-STIFF SUPPORT WIRE GUIDE PERFORATED THE ILIAC VEIN DURING INSERTION OF THE WIRE. UPON INSERTION OF AN UNKNOWN SHEATH, THE PERFORATION REPORTEDLY ENLARGED. PER THE REPORTER, A CORONARY ANGIOGRAM WAS PERFORMED. THE PERFORATION RESULTED IN BLEEDING. THE PATIENT DIED THREE DAYS AFTER THE PROCEDURE. THE PHYSICIAN STATED THAT THE WIRE WAS ¿TOO RIGID¿ AND THE PATIENT HAD FRAGILE VEINS, WHICH PER THE PHYSICIAN, CAUSED THE PERFORATION. PER THE OTHER MANUFACTURER, THERE WERE ¿NO PERFORMANCE ISSUES WITH THE SHEATH¿. THERE HAS BEEN NO ALLEGED MALFUNCTION OF THE COOK WIRE GUIDE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THIS TIME.
Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation of Vessels
MAUDE report 24481431 ↗DeathDec 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED, DURING A PULSED FIELD ABLATION (PFA) PROCEDURE, THE PATIENT EXPERIENCED A PERICARDIAL EFFUSION AND EXPIRED. ANOTHER MANUFACTURER'S CATHETER WAS PLACED IN THE CORONARY SINUS (CS). ANOTHER MANUFACTURER'S 13F INTRODUCER WAS THEN INTRODUCED INTO THE RIGHT ATRIUM AND TRANSSEPTAL PUNCTURE WAS PERFORMED IN ONE ATTEMPT WITH ANOTHER MANUFACTURER'S TRANSSEPTAL NEEDLE. 10,000 INTERNATIONAL UNITS (I.U.) OF HEPARIN WERE ADMINISTERED TO THE PATIENT. AFTER PREPARING THE OTHER MANUFACTURER'S CATHETER, THE CATHETER WAS ADVANCED OVER A SAFE-T-J AMPLATZ EXTRA-STIFF SUPPORT WIRE GUIDE AND INTO THE LEFT ATRIUM. A SHADOW WAS THEN OBSERVED AROUND THE HEART SILHOUETTE ON X-RAY AND A DECREASE IN SYSTOLIC BLOOD PRESSURE WAS NOTED FROM 100 TO 70 WITHIN 1-2 MINUTES. AN ECHOCARDIOGRAM WAS DONE WHICH REVEALED A LARGE PERICARDIAL EFFUSION. A PERICARDIOCENTESIS WAS PERFORMED BUT WAS VERY CHALLENGING DUE TO THE PATIENT'S BODY MASS (125KG), THE POSITION OF THE PATIENT¿S LIVER (IN FRONT OF THE PUNCTURE AREA), AND SIMULTANEOUS RESUSCITATION EFFORTS. SEVERAL ATTEMPTS WERE NEEDED TO ACHIEVE THE PUNCTURE AND INTRODUCE THE DRAIN INTO THE PERICARDIUM. AFTER MORE THAN 60 MINUTES OF RESUSCITATION AND DRAINI
Patient problems: Cardiac Perforation; Exsanguination; Low Blood Pressure/ Hypotension; Perforation of Vessels; Pericardial Effusion
MAUDE report 23935218 ↗MalfunctionNov 6, 2025Flaked; Flaked
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23487463 ↗MalfunctionSep 15, 2025Material Protrusion/Extrusion; Material Protrusion/Extrusion
AS REPORTED, UPON OPENING THE UNDAMAGED DEVICE PACKAGE, PRIOR TO USE FOR AN UNSPECIFIED PROCEDURE INVOLVING PLACEMENT OF A STENT, THE TIP OF AN AMPLATZ EXTRA-STIFF SUPPORT WIRE GUIDE WAS FOUND TO BE DAMAGED. THE DEVICE DID NOT MAKE PATIENT CONTACT, AND ANOTHER WIRE WAS USED TO COMPLETE THE PROCEDURE. A PHOTO PROVIDED BY THE CUSTOMER SHOWS THE MANDRIL PROTRUDING FROM THE WIRE. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES OR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23051634 ↗MalfunctionSep 11, 2025Break; Break
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: Insufficient Information
MAUDE report 23025953 ↗MalfunctionSep 8, 2025Unraveled Material; Material Protrusion/Extrusion; Unraveled Material; Material Protrusion/Extrusion
UPON PRELIMINARY EVALUATION OF THE RETURNED DEVICES ON (B)(6) 2025, THE INNER WIRE WAS PROTRUDING NEAR THE DISTAL END OF BOTH DEVICES.
Patient problems: Insufficient Information
MAUDE report 22996024 ↗MalfunctionAug 25, 2025Flaked; Flaked
AS REPORTED, DURING URETEROSCOPY PROCEDURE, THE COATING OF THE 'AMPLATZ ULTRA STIFF PTFE DOUBLE FLEXIBLE WIRE GUIDE' FLAKED OFF INTO THE PATIENT. ADDITIONAL INFORMATION REGARDING THE EVENT AND PATIENT OUTCOME HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 22883021 ↗MalfunctionAug 19, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
AS REPORTED, FOREIGN MATTER RESEMBLING A HAIR WAS NOTED WITHIN AN AMPLATZ EXTRA-STIFF SUPPORT WIRE GUIDES STERILE PACKAGE. THIS WAS NOTED WITHIN A DISTRIBUTION FACILITY. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22842726 ↗MalfunctionAug 6, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
AS REPORTED, A HAIR OR HAIR-LIKE FOREIGN MATTER WAS DISCOVERED INSIDE THE PACKAGING OF THE 'SAFE-T-J AMPLATZ EXTRA-STIFF SUPPORT WIRE GUIDE'. THE ISSUE WAS NOTED DURING DEVICE INSPECTION WITHIN A DISTRIBUTION FACILITY, THEREFORE, THERE IS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22730916 ↗MalfunctionJul 23, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
NO ADDITIONAL INFORMATION REGARDING PATIENT AND/OR EVENT DETAILS HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22579442 ↗MalfunctionJun 25, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
AS REPORTED, PRIOR TO USE FOR AN UNKNOWN PROCEDURE IN INTERVENTIONAL RADIOLOGY, FOREIGN MATTER RESEMBLING A HAIR WAS NOTED IN AN AMPLATZ STIFF SUPPORT WIRE GUIDE'S SEALED STERILE PACKAGE. THE DEVICE DID NOT MAKE PATIENT CONTACT. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES OR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22332226 ↗MalfunctionMay 13, 2025Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED AN AMPLATZ EXTRA STIFF PTFE FIXED CORE WIRE GUIDE CAME OUT OF THE CASING AND PART OF IT WAS DAMAGED. THE ISSUE WAS FOUND IN THE UNOPENED PACKAGE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22009592 ↗MalfunctionMay 5, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT A HAIR-LIKE SUBSTANCE WAS FOUND INSIDE THE PACKAGING OF AN AMPLATZ EXTRA STIFF SUPPORT WIRE GUIDE. UPON OPENING THE PACKAGE, A NURSE NOTICED THE FOREIGN MATTER PRIOR TO A BILIARY DRAINAGE PROCEDURE, DURING WHICH A DRAINAGE TUBE WAS TO BE INSERTED PERCUTANEOUSLY INTO THE RIGHT BILE DUCT BRANCH. THE PROCEDURE WAS COMPLETED USING A NEW SAME-LIKE DEVICE. IT WAS CONFIRMED THAT NO DAMAGE TO THE PACKAGE WAS NOTICED, AND THE DEVICE WAS STORED VERTICALLY. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21963657 ↗InjuryApr 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AS REPORTED, DURING A PROCEDURE INVOLVING ANEURYSM REPAIR AND STENT GRAFT PLACEMENT, DURING WHICH A SAFE-T-J ROSEN CATHETER EXCHANGE WIRE GUIDE (REPORTED UNDER PATIENT IDENTIFIER (B)(6)) AND A SAFE-T-J AMPLATZ EXTRA-STIFF SUPPORT WIRE GUIDE (REPORTED UNDER PATIENT IDENTIFIER (B)(6)) WERE USED, THE PATIENT EXPERIENCED A DISSECTION OF THE LEFT SUBCLAVIAN ARTERY. GENERAL ANESTHESIA WAS ADMINISTERED FOR THE PROCEDURE, AND PERCUTANEOUS ACCESS WAS OBTAINED IN THE LEFT AND RIGHT FEMORAL ARTERIES. CUT-DOWN ACCESS WAS OBTAINED IN THE RIGHT AXILLARY ARTERY. A 9X57 PERIPHERAL STENT WAS SUCCESSFULLY PLACED IN THE LEFT SUBCLAVIAN ARTERY, WHICH WAS RE-VASCULARIZED WITH A FENESTRATED BRANCHED DEVICE. STENT PATENCY WAS MAINTAINED, WITH NORMAL END ARTERY PERFUSION. THE WIRES USED DURING THE PROCEDURE SUCCESSFULLY ACCESSED THE TARGET VASCULATURE AND PERFORMED AS INTENDED, WITHOUT ANY NOTED DEVICE DEFICIENCIES. A LEFT SUBCLAVIAN ARTERY INJURY (DISSECTION) WAS REPORTED DURING THE PROCEDURE; HOWEVER, THE INJURY DID NOT REQUIRE TREATMENT. PER THE REPORTER, THE INJURY WAS CAUSALLY RELATED TO A STENT, AS THE DISSECTION OCCURRED AFTER PLACEMENT OF THE BRIDGING STENT, WHILE POSITIONING THE DEVICE. PER THE R
Patient problems: Vascular Dissection
MAUDE report 21753451 ↗
Other Cook Incorporated products
All Cook Incorporated 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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