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OptiFlex M0063903000Recalls & reported problems

Boston Scientific Corporation · Nitinol Stone Retrieval Basket · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729767596), received between Nov 28, 2017 and Nov 28, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

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.

Most reported problems

Device problems

  • Break1

Patient problems

  • No Consequences Or Impact To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionNov 28, 2017Break; Break

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OPTIFLEX NITINOL RETRIEVAL BASKET WAS USED DURING A PROCEDURE FOR SIALOLITHIASIS PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, THE OPTIFLEX BASKET WAS TESTED AND IT WAS FOUND THAT THE BASKET WOULD NOT OPEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER OPTIFLEX BASKET. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS; PULL WIRE BROKEN.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7063130 ↗

Other DISLODGER, STONE, BASKET, URETERAL, METAL devices

All DISLODGER, STONE, BASKET, URETERAL, METAL devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.