Zilver Flex 35 G50167Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10827002501673), received between Mar 31, 2016 and Apr 14, 2022 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Off-Label Use” (4 reports).

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 14, 2022Off-Label Use; Difficult to Advance; Difficult or Delayed Separation; Off-Label Use; Difficult to Advance; Difficult or Delayed Separation

  AS REPORTED, DURING TREATMENT OF A CHRONIC TOTAL OBSTRUCTION IN THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA), A ZILVER FLEX 35 BILIARY SELF-EXPANDING STENT WOULD NOT DEPLOY. ACCESS WAS OBTAINED IN THE LEFT COMMON FEMORAL ARTERY. THE LESION WAS CROSSED WITH ANOTHER MANUFACTURER'S WIRE GUIDE AND A COOK 5 FRENCH, 55-CENTIMETER ANSEL SHEATH, AND WAS THEN BALLOONED WITH A COOK 35LP BALLOON. THE ANATOMY WAS NOT SEVERELY TORTUOUS OR CALCIFIED. ANOTHER MANUFACTURER'S 6X15 STENT WAS PLACED ON THE DISTAL END OF THE SFA, AS DEFECTION FLAPS WERE NOTED. AN ARTERIOGRAM WAS OBTAINED AND THE PHYSICIAN NEEDED TO EXTEND THE OTHER MANUFACTURER'S STENT. THE COMPLAINT DEVICE WAS THEN INSERTED, AFTER FLUSHING THE DEVICE, AND WAS NOTED TO GET "CAUGHT UP" ON THE OTHER MANUFACTURER'S STENT WHILE WATCHING THE ARTERIOGRAM. THE PHYSICIAN PUSHED THE DEVICE FORWARD WITH MORE FORCE. UPON ATTEMPTED DEPLOYMENT OF THE STENT, IT WOULD NOT DEPLOY. THE DEVICE WAS REMOVED AND A PTX STENT WAS USED TO COMPLETE THE PROCEDURE, WITH NO FURTHER COMPLICATIONS. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL R

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14114557 ↗
• InjuryJul 14, 2021Fracture; Off-Label Use; Adverse Event Without Identified Device or Use Problem; Fracture; Off-Label Use; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT'S PHYSICIAN ON 04APR2022. THE PATIENT HAD A HISTORY OF A LEFT FEMORAL-POPLITEAL BYPASS WITH REVISION IN 2010 FOR ISCHEMIA. IN (B)(6)OF 2021, THE PATIENT PRESENTED WITH STENOSIS OF THE RIGHT EXTERNAL ILIAC AND RIGHT SUPERFICIAL FEMORAL ARTERIES, WHERE A PREVIOUS REMOTE ENDARTERECTOMY HAD BEEN PERFORMED. IN (B)(6) OF 2021, THE PATIENT UNDERWENT PERCUTANEOUS TREATMENT OF THE TWO RIGHT-SIDED LESIONS, VIA LEFT FEMORAL ACCESS WITH ULTRASOUND GUIDANCE. THE PROCEDURE SUCCESSFULLY RESTORED PATENCY AND BLOOD FLOW TO THE RIGHT LEG, USING ANOTHER MANUFACTURER'S STENT IN THE RIGHT EXTERNAL ILIAC ARTERY AND A ZILVER FLEX 6-140 IN THE RIGHT SUPERFICIAL FEMORAL ARTERY. AFTER THE PROCEDURE WAS COMPLETED, THE PATIENT DEVELOPED PAIN AND HYPOTENSION AND WAS FOUND TO HAVE BLEEDING FROM THE LEFT FEMORAL ACCESS SITE. THE PATIENT WAS TREATED WITH NEW LEFT FEMORAL ACCESS AND TEMPORARY TAMPONADE OF THE AREA WITH INTRALUMINAL BALLOON PLACEMENT, FOLLOWED BY VOLUME RESUSCITATION AND PLACEMENT OF ANOTHER MANUFACTURER'S STENT OVER THE BLEEDING ACCESS SITE IN THE LEFT DISTAL EXTERNAL ILIAC/PROXIMAL COMMON FEMORAL ARTERIES. THE PATIENT WAS THEN TRANSFERRED TO TH

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Low Blood Pressure/ Hypotension

  MAUDE report 12168727 ↗
• MalfunctionJan 11, 2021Off-Label Use; Difficult to Advance; Off-Label Use; Difficult to Advance

  NO NEW PATIENT OR EVENT INFORMATION TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11147816 ↗
• MalfunctionOct 19, 2020Premature Activation; Off-Label Use; Premature Separation; Premature Activation; Off-Label Use; Premature Separation

  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; No Consequences Or Impact To Patient

  MAUDE report 10702357 ↗
• MalfunctionSep 17, 2019Premature Activation; Premature Activation

  ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2019 NOTING THAT THE TARGET LESION WAS WITHIN THE CONTRALATERAL SUPERFICIAL FEMORAL ARTERY (SFA), AND THE WIRE GUIDE USED DURING THE PROCEDURE WAS A COOK STIFF GLIDE WIRE. ADDITIONALLY, INFORMATION RECEIVED (B)(6) 2019 CONFIRMED THAT THE CUSTOMER DOES NOT RECALL ANY DAMAGE TO THE DEVICE PRIOR TO THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9078018 ↗
• InjuryMar 31, 2016Fracture; Fracture

  WHILE PERFORMING AN ANGIOGRAM PROCEDURE ON A (B)(6) MALE PATIENT WITH PVD, TWO STENTS WERE FRACTURED IN MULTIPLE PLACES. THIS WAS CONFIRMED ON (B)(6) 2016. THE STENTS REMAIN INSIDE THE PATIENT'S BODY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT EXPERIENCED VESSEL OCCLUSION DUE TO THE STENT FRACTURE. THE PATIENT DID REQUIRE ADDITIONAL BALLOON ANGIOPLASTY AND RESTENTING PROCEDURES.

  Patient problems: No Code Available; Occlusion

  MAUDE report 5538459 ↗