PROWLER 606-051FXRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886704028529), received between May 6, 2020 and May 6, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (1 report).

1 other recall cover devices cleared under the same FDA submission (K003925, K993266); 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMay 6, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  A REPORT FROM THE FIELD INDICATED THAT SHORTLY BEFORE A 2X4 HYPERSOFT (MICROVENTION) COIL WAS COMPLETELY INSIDE THE ANEURYSM AND ABOUT TO BE DETACHED, THE COIL COULD NEITHER BE PUSHED NOR PULLED. THE PROWLER10 45TIP 2MRK (606051FX/17751954) PRE-SHAPED MICROCATHETER WAS ¿STRETCHED SO THE COIL TORN THROUGH¿. THE COIL WAS DAMAGED ¿AT THE JOINT BETWEEN THE COIL ITSELF AND THE PUSHER WIRE¿. PART OF THE COIL REMAINED IN THE CATHETER AND THE REST OF THE COIL IN THE PATIENT. THE ¿STRETCHED¿ COIL WAS ¿CATCHED¿ IN THE LONG SHEATH USING A STENT RETRIEVER. THERE WAS NO REPORT OF ADVERSE OUTCOME TO THE PATIENT. A 3X10 HYPERSOFT (MICROVENTION) COIL WAS USED PRIOR TO THE COMPLAINT COIL AND THERE WERE NO ISSUES ENCOUNTERED DURING ADVANCEMENT OR DETACHMENT. THE MICROCATHETER HAD NOT BEEN RE-SHAPED AFTER REMOVAL FROM THE PACKAGING AND THE DEVICE HAD NOT BEEN INSERTED THROUGH A STOPCOCK INSTEAD OF A HEMOSTASIS VALVE. THE PHYSICIAN DID NOT HAVE ¿ANY PROBLEMS WHILE PROBING THE VESSELS WITH MICROWIRE AND MICROCATHETER¿. THE COMPLAINT MICROCATHETER AND PART OF THE 2X4 HYPERSOFT COIL WILL BE RETURNED FOR EVALUATION. NO FURTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION RECEIVED ON 05-MAY-2020 INDICA

  Patient problems: Hemorrhage, Subarachnoid

  MAUDE report 10028646 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K003925, K993266. One submission often covers many models, so check the product and lot details in each record.

• Z-0018-04 · Oct 19, 2001 · Terminated
  Product is labeled as Cordis Pre-shaped Prowler Plus MP Infusion Catheter (3 F proximal OD, 2.3 F Distal OD, 45 cm distal length, total length 155 cm) with an MP (45 degree) dual