POWERFLEX 4159040SRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 20705032002032), received between Jun 12, 2019 and Nov 17, 2020 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (3 reports).

1 other recall cover devices cleared under the same FDA submission (K032737); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 17, 2020Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE 9MM X 4CM X 80CM POWERFLEX EXTREME PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED BELOW RATED BURST PRESSURE (RBP) AT APPROXIMATELY EIGHT (8) ATMOSPHERES (ATM) WHEN TREATING A LESION IN THE CEPHALIC ARCH. THEREFORE, THE BALLOON WAS REMOVED INTACT AND A SECOND BALLOON OF THE SAME SIZE AND MANUFACTURER WAS USED TO SUCCESSFULLY COMPLETE THE CASE. THERE WAS NO HARM CAUSED AND NO REPORTED PATIENT INJURY. THE LESION WAS NOT CALCIFIED, WAS 80 PERCENT STENOSED, HAD LITTLE TORTUOSITY AND WAS NOT USED FOR A CHRONIC TOTAL OCCLUSION. THE DEVICE WAS STORED AND HANDLED AS PER THE INSTRUCTION FOR USE (IFU). THERE WAS NO DAMAGE NOTED TO THE PACKAGING OF THE DEVICE. THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP, PROTECTIVE BALLOON COVER, STYLET OR ANY OF THE STERILE PACKAGING COMPONENTS. THERE WERE NO KINKS OR OTHER DAMAGES NOTED PRIOR TO INSERTING THE PRODUCT THE PRODUCT INTO THE PATIENT. THE DEVICE PREPPED NORMALLY. GE OMNIPAQUE WITH 50/50 CONTRAST TO SALINE RATIO WAS USED. A NON CORDIS INDEFLATOR WAS USED AND WAS USED SUCCESSFULLY WITH OTHER DEVICES. THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC V

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10852632 ↗
• MalfunctionJun 29, 2020Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOON OF 9MM X 40MM X 80CM POWERFLEX EXTREME PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED INTRASTENT. THE BALLOON WAS DELIVERED WITHOUT INCIDENT TO A TARGET LESION AND INFLATED TO 10 ATMOSPHERE (ATM) ONCE AND RUPTURED. THERE WAS NO REPORTED PATIENT INJURY. THE VESSEL LEVEL OF ANGULATION IS MILD. THE VESSEL LEVEL OF CALCIFICATION OR TORTUOSITY IS NONE. THE DEVICE WAS PREPPED PER THE INSTRUCTIONS FOR USE (IFU) AND IT WAS PREP NORMALLY. THE CONTRAST TO SALINE RATIO WAS 50/50. THE SAME INDEFLATOR WAS USED SUCCESSFULLY WITH OTHER DEVICES. THE BALLOON INFLATED NORMALLY. THE CATHETER WAS NOT TORQUED AGAINST RESISTANCE. THERE WERE NO KINK/BENT NOTED AFTER THE DEVICE WAS REMOVED FROM PATIENT. THERE WAS NO UNUSUAL FORCE USED AT ANY TIME DURING THE PROCEDURE. THE DEVICE WAS REMOVED INTACT (IN ONE PIECE) FROM THE PATIENT. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS AS PRODUCT WAS DISCARDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10206604 ↗
• MalfunctionJun 12, 2019Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, AN 9 X 40 MM POWERFLEX EXTREME BALLOON WAS PLACED INTRASTENT AND DURING INFLATION THE BALLOON RUPTURED AT FIFTEEN (15) ATMOSPHERES (ATMS). THERE WAS NO REPORTED PATIENT INJURY. A COMPETITOR'S BALLOON WAS USED TO COMPLETE THE PROCEDURE. THE BALLOON WAS REMOVED FROM THE PATIENT AND INSPECTED. CONTRAST WAS USED TO VERIFY THAT THERE WERE NO REMAINING PIECES LEFT IN THE PATIENT. THE EXAM WAS COMPLETED WITH NO FURTHER COMPLICATIONS. THE TARGET LESION IS THE CEPHALIC ARCH WHICH WAS EIGHTY PERCENT (80%) STENOSIS. THE USER FEELS THAT THE STENT MAY HAVE CAUSED THE BALLOON TO RUPTURE. THE DEVICE WAS PREP ACCORDING TO THE INSTRUCTION FOR USE (IFU) WITH NO DIFFICULTY NOTED. THERE WERE NO DIFFICULTIES REMOVING THE PRODUCT FROM THE HOOP, THE PROTECTIVE BALLOON COVER, THE STYLET OR ANY OF THE STERILE PACKAGING COMPONENTS. THERE WERE NO KINKS OR OTHER DAMAGES NOTED PRIOR TO INSERTING THE PRODUCT THE PRODUCT INTO THE PATIENT. A COMPETITOR'S CONTRAST MEDIA AND INFLATION DEVICE WAS USED WITH AN ONE TO ONE RATIO. THE INFLATION DEVICE WAS SUCCESSFULLY USED WITH OTHER DEVICES. THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE OR THE GUIDE CATH

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8692541 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K032737. One submission often covers many models, so check the product and lot details in each record.

• Z-1477-2020 · Jan 8, 2020 · Terminated
  Cordis POWERFLEX P3, PTA Dilation Catheter, REF 420-6020S