Scoreflex NC Scoring PTCA Catheter 622-204-1URecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 06934955936333), received between Jul 3, 2024 and Jul 11, 2024 — classified as 2 injuries.

The most frequently reported specific device problem is “Failure to Deflate” (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. 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJul 11, 2024No Apparent Adverse Event; No Apparent Adverse Event

  A SCOREFLEX NC SCORING BALLOON WAS USED FOR TREATMENT OF A HEAVILY CALCIFIED, 85% STENOSED LESION IN MID LEFT ANTERIOR DESCENDING (LAD) ARTERY VIA RIGHT RADIAL APPROACH. A 6FR GUIDING CATHETER WAS USED TO DEPLOY THE BALLOON TO THE LESION. NO RESISTANCE WAS FELT WHILE ADVANCING THE BALLOON. THE SCOREFLEX WAS INFLATED AT NOMINAL PRESSURE IN MID LAD ARTERY TOTALLY OCCLUDING IT. THE SCOREFLEX COULD NOT BE DEFLATED. USING DIFFERENT INDEFLATORS, SYRINGES AND OTHER UNSPECIFIED DEVICES DID NOT RESOLVE THE ISSUE. WIRE CUTTERS FROM THE OPERATING ROOM (OR) WERE USED TO CUT THE BALLOON SHAFT AT THE HUB TO GET IT TO DEFLATE BUT THE BALLOON REMAINED INFLATED. A GUIDE EXTENSION CATHETER WAS PLACED OVER THE CUT SHAFT TO WEDGE THE BALLOON DOWN AS MUCH AS POSSIBLE. WITH SOME GENTLE PULLING, THEY WERE ABLE TO GET THE BALLOON TO THE GUIDE EXTENSION CATHETER AND PULLED THE WHOLE SYSTEM OUT TOGETHER. THE USE OF THE GUIDE EXTENSION CATHETER WAS UNPLANNED AND REACTIVE TO THE BALLOON NOT DEFLATING. THE BALLOON REMAINED INFLATED HOURS LATER DESPITE THE CUT SHAFT. TO COMPLETE THE PROCEDURE, BALLOON ANGIOPLASTY AND STENT PLACEMENT WERE PERFORMED USING ABBOTT BMW GUIDE WIRE FOR DEVICE DELIVERY. THERE WAS A THR

  Patient problems: Unspecified Heart Problem

  MAUDE report 19718052 ↗
• InjuryJul 3, 2024Failure to Deflate; Failure to Deflate

  A SCOREFLEX NC SCORING BALLOON WAS USED FOR TREATMENT OF A HEAVILY CALCIFIED, 85% STENOSED LESION IN MID LEFT ANTERIOR DESCENDING (LAD) ARTERY VIA RIGHT RADIAL APPROACH. A 6FR GUIDING CATHETER WAS USED TO DEPLOY THE BALLOON TO THE LESION. NO RESISTANCE WAS FELT WHILE ADVANCING THE BALLOON. THE SCOREFLEX WAS INFLATED AT NOMINAL PRESSURE IN MID LAD ARTERY TOTALLY OCCLUDING IT. THE SCOREFLEX COULD NOT BE DEFLATED. USING DIFFERENT INDEFLATORS, SYRINGES AND OTHER UNSPECIFIED DEVICES DID NOT RESOLVE THE ISSUE. WIRE CUTTERS FROM THE OPERATING ROOM (OR) WERE USED TO CUT THE BALLOON SHAFT AT THE HUB TO GET IT TO DEFLATE BUT THE BALLOON REMAINED INFLATED. A GUIDE EXTENSION CATHETER WAS PLACED OVER THE CUT SHAFT TO WEDGE THE BALLOON DOWN AS MUCH AS POSSIBLE. WITH SOME GENTLE PULLING, THEY WERE ABLE TO GET THE BALLOON TO THE GUIDE EXTENSION CATHETER AND PULLED THE WHOLE SYSTEM OUT TOGETHER. TO COMPLETE THE PROCEDURE, BALLOON ANGIOPLASTY AND STENT PLACEMENT WERE PERFORMED USING ABBOTT BMW GUIDE WIRE FOR DEVICE DELIVERY. THERE WAS A THREE-MINUTE DELAY TO THE PROCEDURE BUT NO HARM TO THE PATIENT.

  Patient problems: Reduced Blood Flow

  MAUDE report 19671138 ↗