ReShape™ Removal Catheter RSM210Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI B001RSM2101), received between Aug 7, 2018 and Dec 12, 2018 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Retraction Problem” (2 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 18, 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.

• MalfunctionDec 12, 2018Retraction Problem; Retraction Problem

  THE BALLOON WAS INSERTED ON (B)(6) 2018. DURING THE ROUTINE REMOVAL ON (B)(6) 2018, THE NEEDLE DID NOT RETRACT BACK INTO THE PLASTIC HOUSING AFTER PUNCTURING THE PROXIMAL BALLOON. THE PHYSICIAN OPENED A NEW REMOVAL TOOL TO DEFATE THE DISTAL BALLOON.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8156010 ↗
• MalfunctionSep 14, 2018Material Puncture/Hole; Detachment of Device or Device Component; Material Puncture/Hole; Detachment of Device or Device Component

  THE BALLOON WAS INSERTED ON (B)(6) 2018. ON (B)(6) 2018 DURING A ROUTINE REMOVAL, THE NEEDLE FROM THE REMOVAL CATHETER DETACHED WHILE ATTEMPTING TO DEFLATE THE DISTAL BALLOON. THE NEEDLE WAS RECOVERED BY THE PHYSICIAN DURING THE PROCEDURE. THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7876614 ↗
• MalfunctionAug 7, 2018Retraction Problem; Retraction Problem

  DURING REMOVAL, THE PHYSICIAN PUNCTURED THE FIRST BALLOON AND COULDN'T RETRACT THE NEEDLE BACK INTO THE CATHETER. THE PHYSICIAN DEFLATED THE 2ND BALLOON WITH A NEEDLE ASPIRATOR. A RESHAPE FIELD SPECIALIST WAS ASSISTING WITH THE REMOVAL TRYING TO GET THE NEEDLE TO RETRACT. HOWEVER, THE NEEDLE WAS JAMMED DURING THE RETRACTING PHASE AND ENDED UP ADVANCING WHICH RESULTED IN THE FIELD SPECIALIST BEING PUNCTURED. THE PATIENT HAD BOTH BALLOONS REMOVED.

  Patient problems: Needle Stick/Puncture; No Patient Involvement

  MAUDE report 7758734 ↗