Flexor G49101Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00827002491014), received between Oct 27, 2016 and Sep 24, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (1 report).

1 FDA recall record name this device's 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, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Nov 26, 2025Open, Classified

   Cook Medical identified that products supplied in the affected device lots may have been manufactured out of specification. Impacted products may have been cut to the incorrect length, not correctly trimmed, and not inspected properly.

   Z-0993-2026 · Root cause: Process control · FDA record ↗

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.

• MalfunctionSep 24, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  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 20295829 ↗
• MalfunctionMar 13, 2023Peeled/Delaminated; Unraveled Material; Peeled/Delaminated; Unraveled Material

  AS ORIGINALLY REPORTED, PRIOR TO USE FOR A PROCEDURE INVOLVING STENT PLACEMENT IN THE DISTAL AORTA, THE DILATOR WAS UNABLE TO BE INSERTED INTO A FLEXOR ANSEL GUIDING SHEATH. THE DEVICE WAS REMOVED FROM THE PACKAGING AND FLUSHED PER THE INSTRUCTIONS FOR USE (IFU); HOWEVER, RESISTANCE WAS ENCOUNTERED UPON ATTEMPTED INSERTION OF THE DILATOR INTO THE SHEATH. THE EVENT OCCURRED PRIOR TO PATIENT CONTACT, AND A NEW SHEATH WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.UPON EVALUATION OF THE COMPLAINT DEVICE, THE SHEATH WAS FOUND TO BE DELAMINATED AND THE COIL WAS EXPOSED AFTER THE HUB WAS DISASSEMBLED AND THE DILATOR WAS INSERTED INTO THE SHEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16531061 ↗
• MalfunctionOct 27, 2016Split; Split

  IT WAS REPORTED THAT DURING THE RETRIEVAL OF ANOTHER MANUFACTURER'S FILTER, THE PHYSICIAN USED A 9FRX45 SHEATH THROUGH AN 11FR SHEATH. THE PHYSICIAN SNARED THE FILTER WITH THE GOOSENECK SNARE AND TRIED UNSUCCESSFULLY TO PUSH THE 9FR SHEATH OVER THE FILTER. AN 11FR OVERTOP OF THE 9FR WAS THEN USED TO RETRIEVE BOTH THE FILTER AND THE 9FR SHEATH. UPON EXAMINATION OF THE REMOVED PARTS IT WAS DETERMINED THAT THE TIP OF THE SHEATH SPLIT COMPLETELY OPEN AND THE COILING WAS EXPOSED. NO ADDITIONAL PRODUCTS WERE NEEDED TO RETRIEVE THE DEFECTIVE PRODUCT OR TO FINISH THE PROCEDURE. THE PATIENT OUTCOME WILL BE DETERMINED WHEN ADDITIONAL FOLLOW UP IS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6060448 ↗