PowerCrossRecalls & reported problems across all models
Covidien LP · 12 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 9
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls
- 1
We found 12 models of PowerCross by Covidien LP in the FDA's device registry (GUDID). Together they are named in 9 adverse event reports in the FDA's MAUDE database, received between Mar 29, 2017 and Jul 13, 2018 — classified as 2 injuries, 7 malfunctions.
The most frequently reported specific device problem is “Burst Container or Vessel” (3 reports).
1 FDA recall record name at least one of these models by its device identifier.
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
PowerCross 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.
- Nov 10, 2016Terminated
Medtronic identified an issue with specific models and lots of the PowerCross .018 Over the Wire (OTW) Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter. During an unrelated manufacturing inspection of scrapped products, an out of specification condition was observed. The catheter outer shafts were pinched and deformed at the proximal balloon bond. Bench testing of affected devices showed that this resulted in either the inability to inflate the device, a slow deflation, or the inability to deflate the device post expansion.
Z-0892-2017 · Root cause: Process control · names 5 of these models · Recall details · FDA record ↗
Most reported PowerCross problems
Device problems
- Burst Container or Vessel3
- Deflation Problem2
- Inflation Problem2
- Leak/Splash2
- Component Missing1
- Detachment of Device or Device Component1
- Device Expiration Issue1
- Device Markings/Labelling Problem1
Patient problems
- No Consequences Or Impact To Patient7
- Patient Problem/Medical Problem2
- Device Embedded In Tissue or Plaque1
- No Known Impact Or Consequence To Patient1
PowerCross models
12 models, most reported first. Each model has its own page with its reports, recalls and device details.
- PowerCross AB18W060100150Catheter, angioplasty, peripheral, transluminal1 recall1 report
- PowerCross AB18W025040150Catheter, angioplasty, peripheral, transluminal1 recall0 reports
- PowerCross AB18W030100150Catheter, angioplasty, peripheral, transluminal1 recall0 reports
- PowerCross AB18W040100150Catheter, angioplasty, peripheral, transluminal1 recall0 reports
- PowerCross AB18W050040150Catheter, angioplasty, peripheral, transluminal1 recall0 reports
- PowerCross AB18W060060150Catheter, angioplasty, peripheral, transluminal2 reports
- PowerCross AB18W020100090Catheter, angioplasty, peripheral, transluminal1 report
- PowerCross AB18W040040090Catheter, angioplasty, peripheral, transluminal1 report
- PowerCross AB18W030060150Catheter, angioplasty, peripheral, transluminal1 report
- PowerCross AB18W030120150Catheter, angioplasty, peripheral, transluminal1 report
- PowerCross AB18W050150150Catheter, angioplasty, peripheral, transluminal1 report
- PowerCross AB18W050200150Catheter, angioplasty, peripheral, transluminal1 report
Recent PowerCross adverse event reports
The 9 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionJul 13, 2018Component Missing; Detachment of Device or Device Component; Device Markings/Labelling Problem; Component Missing; Detachment of Device or Device Component
THE PHYSICIAN WAS ATTEMPTING TO USE BALLOON ANGIOPLASTY TREAT A 100MM PLAQUE LESION WITH 75% STENOSIS AND NO CALCIFICATION IN THE MID LEFT SUPERFICIAL FEMORAL ARTERY (SFA) USING A POWERCROSS DEVICE AND A NITREX 18 300CM GUIDEWIRE. NO TORTUOSITY WAS REPORTED. PRE-DILATION WAS PERFORMED WITH 3X60 DEVICE (8ATMS AND ONE INFLATION). AFTER PRE-DILATION A 4X120 DEVICE WAS USED (7 ATM AND 1 INFLATION). THE POWERCROSS BALLOON USUALLY HAS TWO RADIOPAQUE MARKERS BUT IT WAS NOTICED WHILE POSITIONING THE BALLOON THAT THE PROXIMAL MARKER ON THE BALLOON WAS NOT VISIBLE. THE BALLOON WAS GIVEN OPAQUE SHAPE SLIGHTLY TO SEE THE LENGTH OF THE BALLOON. THE ISSUE WAS NOTICED AFTER THE PRODUCT WAS SENT INTO THE PATIENT. THE MARKER WAS NOT INITIALLY VISIBLE IN THE PATIENT AND IT WAS REPORTED THAT IT DID NOT FALL OFF INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED NORMALLY.
Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient
MAUDE report 7684711 ↗InjuryApr 17, 2018Deflation Problem; Deflation Problem
THE PHYSICIAN WAS ATTEMPTING TO USE A POWERCROSS BALLOON TO TREAT AN ARTERIOVENOUS FISTULA(AVF). THE DEVICE WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. THERE WAS NO RESISTANCE ENCOUNTERED ADVANCING THE DEVICE AND NO EXCESSIVE FORCE WAS USED. NO EMBOLIC PROTECTION WAS USED. THE BALLOON WAS INFLATED USING A AC3200 INFLATION DEVICE WITH 50/50 CONTRAST SALINE SOLUTION. THE DEVICE WAS REPORTED TO HAVE BEEN INFLATED TO A NORMAL ATM PRESSURE WITH NO ISSUES. IT WAS REPORTED THE PHYSICIAN WAS UNABLE TO DEFLATE THE DEVICE AND USED A NEEDLE TO PUNCTURE THE BALLOON THROUGH THE SKIN. THE BALLOON WAS THEN REMOVED. THERE WAS NO DAMAGE OR KINKING NOTED TO THE DEVICE.
Patient problems: Patient Problem/Medical Problem
MAUDE report 7435614 ↗InjuryMar 8, 2018Burst Container or Vessel; Burst Container or Vessel
THE PHYSICIAN WAS ATTEMPTING TO USE A POWERCROSS BALLOON TO TREAT A SEVERELY CALCIFIED AND SLIGHTLY TORTUOUS MID LEFT ILIAC ARTERY LESION EXHIBITING 100% OCCLUSION. THE DEVICE WAS USED WITH A NON-MDT SHEATH <(>&<)> GUIDEWIRE. NO EMBOLIC PROTECTION WAS USED. THE DEVICE WAS REMOVED FROM ITS PACKAGING WITHOUT ISSUE AND INSPECTED WITH NO ISSUES NOTED. THE IFU WAS FOLLOWED DURING THE PROCEDURE. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. IT WAS REPORTED THAT RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE AND THAT EXCESSIVE FORCE WAS USED DURING DELIVERY OF THE DEVICE. DURING THE INITIAL BALLOON INFLATION, USING A SYRINGE AND CONTRAST/SALINE MIX, A BALLOON BURST OCCURRED. FOLLOWING THIS, IT WAS REPORTED THAT A FRAGMENT OF THE BALLOON REMAINED IN THE PATIENT. THE PATIENT ATTENDED THE OR WHERE THE BALLOON FRAGMENT WAS REMOVED BY COMMON FEMORAL ENDARTERECTOMY. NO FURTHER PATIENT INJURY WAS REPORTED.
Patient problems: Device Embedded In Tissue or Plaque; Patient Problem/Medical Problem
MAUDE report 7323289 ↗MalfunctionFeb 2, 2018Leak/Splash; Leak/Splash
THE PHYSICIAN WAS ATTEMPTING TO USE A POWERCROSS PTA BALLOON TO TREAT A 140MM MODERATELY CALCIFIED PLAQUE LESION IN THE DISTAL RIGHT SFA (50% STENOSIS). THE ARTERY HAD A DIAMETER OF 5MM AND WAS MODERATELY TORTUOUS. THE DEVICE WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. THE PROCEDURE USED A 6 FR NON-MEDTRONIC SHEATH AND A 0.018" NON-MEDTRONIC GUIDEWIRE. NO RESISTANCE WAS ENCOUNTERED ADVANCING THE DEVICE, THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT AND NO EXCESSIVE FORCE WAS USED. IT WAS REPORTED THAT DURING THE FIRST INFLATION AT 12 ATM PRESSURE, THE CONTRAST FROM THE BALLOON WAS SEEN SEEPING OUT OF THE BALLOON. THE BALLOON WAS DEFLATED AND REMOVED. NO TEAR ON BALLOON WAS OBSERVED, BALLOON REMAINED INTACT. ANOTHER POWERCROSS PTA BALLOON WAS USED TO COMPLETE THE PROCEDURE WITHOUT INCIDENT. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7236534 ↗MalfunctionNov 8, 2017Deflation Problem; Inflation Problem; Leak/Splash; Deflation Problem; Inflation Problem; Leak/Splash
THE PHYSICIAN WAS ATTEMPTING TO USE A POWERCROSS PTA BALLOON TO TREAT A SLIGHTLY TORTUOUS AND SLIGHTLY CALCIFIED DISTAL RIGHT ANTERIOR TIBIAL ARTERY EXHIBITING 50% STENOSIS. EMBOLIC PROTECTION WAS NOT USED. THE DEVICE WAS REMOVED FROM ITS PACKAGING AND INSPECTED WITH NO ISSUES NOTED. A NON-MEDTRONIC INFLATION DEVICE WAS USED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE AND NO EXCESSIVE FORCE WAS USED. IT WAS REPORTED THAT THE PHYSICIAN EXPERIENCED INFLATION DIFFICULTIES AND THAT A CONTRAST LEAK WAS NOTED AT THE PROXIMAL END OF THE BALLOON. IT WAS REPORTED THAT THE PHYSICIAN WAS UNABLE TO DEFLATE THE BALLOON MANUALLY AND THAT THE BALLOON WAS SLOW TO DEFLATE BY ITSELF BEFORE THE BALLOON WAS REMOVED FROM THE PATIENT. THE PHYSICIAN USED ANOTHER BALLOON TO COMPLETE THE PROCEDURE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7012254 ↗MalfunctionAug 9, 2017Burst Container or Vessel; Burst Container or Vessel
PHYSICIAN USED A POWERCROSS PTA BALLOON FOR THE TREATMENT OF A MODERATELY CALCIFIED, SLIGHTLY TORTUOUS LESION IN THE MID POPLITEAL ARTERY. LESION EXHIBITED 80% STENOSIS. IT WAS REPORTED THAT RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE, BUT EXCESSIVE FORCE WAS NOT USED. DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. A LONGITUDINAL BALLOON BURST IS REPORTED AT A PRESSURE OF 13ATMS DURING INFLATION. ALL FRAGMENTS WERE RETRIEVED AND A NEW BALLOON WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6776192 ↗MalfunctionJun 8, 2017Inflation Problem; Difficult to Remove; Retraction Problem; Inflation Problem; Difficult to Remove; Retraction Problem
PHYSICIAN USED A POWERCROSS PTA BALLOON FOR TREATMENT IN THE SUPERFICIAL FEMORAL ARTERY WITHOUT THE USE OF EMBOLIC PROTECTION. THERE WAS NO DAMAGING TO PACKAGING AND DEVICE WAS PREPPED AS PER IFU WITHOUT ISSUE. IT WAS REPORTED THAT THE PHYSICIAN EXPERIENCED INFLATION DIFFICULTIES. WHEN THE PHYSICIAN ATTEMPTED TO REMOVE THE BALLOON FOLLOWING INFLATION, DIFFICULTY WAS ENCOUNTERED AS THE BALLOON WOULD NOT COME BACK THROUGH THE SHEATH. THE SHEATH, WIRE, AND BALLOON WERE REMOVED AS ONE TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6628334 ↗MalfunctionJun 2, 2017Device Expiration Issue; Device Expiration Issue
THE PHYSICIAN USED ONE POWERCROSS BALLOON TO TREAT A LESION IN AN UNKNOWN VESSEL. THE DEVICE WAS REMOVED FROM THE PACKAGING AND INSPECTED WITH NO ISSUES NOTED. THE DEVICE WAS USED SUCCESSFULLY WITH NO PROBLEMS. IT WAS REPORTED THAT THE DEVICE WAS USED APPROXIMATELY ONE MONTH POST EXPIRY. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6607710 ↗MalfunctionMar 29, 2017Burst Container or Vessel; Burst Container or Vessel
IT WAS REPORTED THAT THE PHYSICIAN ATTEMPTED TO TREAT PATIENT AT THE PROXIMAL SUPERFICIAL FEMORAL ARTERY USING A POWERCROSS BALLOON. TARGET LESION TYPE WAS REPORTED TO BE "SOFT TISSUE" WITH NO TORTUOSITY, NO CALCIFICATION AND 100% STENOSIS (CTO). IT IS REPORTED THAT BALLOON BURST DURING INFLATION TO 6 ATM WITH AN EVEREST INFLATION DEVICE. IT WAS REPORTED THAT NONE OF THE COMPONENTS DETACHED OR EMBOLIZED. THE PROCEDURE WAS REPORTED TO HAVE BEEN COMPLETED USING ANOTHER BALLOON. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6442428 ↗
Other Covidien LP products
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- LigaSure32 models · 7,283 reports · 1 recall
- Tri-Staple 2.037 models · 4,892 reports · 2 recalls
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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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