Scoreflex NC Scoring PTCA Catheter 625-104-1URecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 06934955936340), received between Nov 29, 2023 and May 14, 2025 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Rupture” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryMay 14, 2025Material Rupture; Material Rupture

  IT WAS REPORTED A 2.5 X 10MM SCOREFLEX NC SCORING BALLOON WAS USED FOR TREATMENT OF HEAVILY CALCIFIED, MODERATELY TORTUOUS, 90% STENOSED LESION IN PROXIMAL TO MID LEFT ANTERIOR DESCENDING ARTERY (LAD) THROUGH FEMORAL ARTERY ACCESS. A NON-ABBOTT GUIDE CATHETER AND NON-ABBOTT GUIDE WIRE WERE IN USE. TWO INFLATIONS WERE PERFORMED. FOLLOWING THE SECOND INFLATION AT 20 ATMOSPHERES, THE BALLOON BURST. THE RUPTURE DID NOT RESULT IN MATERIAL SEPARATION; THE SCOREFLEX WAS FULLY REMOVED. FLOW-LIMITING DISSECTION OF THE DIAGONAL ARTERY WAS SUSPECTED. TREATMENT OF THE DISSECTION WAS ATTEMPTED BUT THE LESION COULD NOT BE CROSSED WITH A NON-ABBOTT GUIDE WIRE. THE LAD WAS STENTED AND THE DIAGONAL ARTERY WAS NOT TREATED. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL THE FOLLOWING DAY AS STANDARD PRACTICE AND THE PATIENT WAS STABLE ON (B)(6) 2025. IN THE OPINION OF THE PHYSICIAN, THE SCOREFLEX BALLOON POSSIBLY CAUSED THE DISSECTION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Obstruction/Occlusion; Vascular Dissection

  MAUDE report 22020352 ↗
• InjuryMay 7, 2025Material Rupture; Material Rupture

  IT WAS REPORTED A 2.5 X 10MM SCOREFLEX NC SCORING BALLOON WAS USED FOR TREATMENT OF HEAVILY CALCIFIED, MODERATELY TORTUOUS LESION IN PROXIMAL TO MID LEFT ANTERIOR DESCENDING ARTERY (LAD). TWO INFLATIONS WERE PERFORMED. FOLLOWING THE SECOND INFLATION AT 20 ATMOSPHERES, THE BALLOON BURST. DISSECTION OF THE DIAGONAL ARTERY WAS SUSPECTED. THE DEVICE IS NOT EXPECTED TO RETURN. BACKGROUND: - PATIENT INFORMATION: NOT SPECIFIED. - LESION INFORMATION: PROXIMAL TO MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. - ASSOCIATED DEVICE: NOT SPECIFIED. - NO RETURNED DEVICE AND CASE IMAGE/CD WERE PROVIDED FOR ANALYSIS. - ADDITIONAL INFORMATION RECEIVED ON 23 APR 2025: Q1. PHYSICIAN FIRST AND LAST NAME? A1. (B)(6). Q2. WHY IS DEVICE NOT RETURNING? (IDENTIFY THE LOCATION E.G DISCARDED? RETAINED BY ACCOUNT?) A2. DISCARDED BY STAFF. Q3. ACCESS SITE? (FEMORAL, RADIAL, ET CETERA) A3. FEMORAL. Q4. % STENOSIS OF LAD? A4. 90%. Q5. GUIDING CATHETER/GUIDE WIRE? (BRAND NAME, TYPE, SIZE) A5. MEDTRONIC LAUNCHER GUIDE CATHETER, ASAHI FIELDER GUIDE WIRE. Q6. DID THE RUPTURE CAUSE ANY MATERIAL SEPARATION? A6. NO. Q7. IF SO, WAS EVERYTHING SUCCESSFULLY RETRIEVED? A7. N/A. Q8. WHAT TYPE OF DISSECTION OCCURRED? (A-F) A8. U

  Patient problems: Vascular Dissection

  MAUDE report 21974735 ↗
• InjuryMay 7, 2025Material Rupture; Material Rupture

  IT WAS REPORTED A 2.5 X 10MM SCOREFLEX NC SCORING BALLOON WAS USED FOR TREATMENT OF HEAVILY CALCIFIED, MODERATELY TORTUOUS LESION IN PROXIMAL TO MID LEFT ANTERIOR DESCENDING ARTERY (LAD). TWO INFLATIONS WERE PERFORMED. FOLLOWING THE SECOND INFLATION AT 20 ATMOSPHERES, THE BALLOON BURST. DISSECTION OF THE DIAGONAL ARTERY WAS SUSPECTED. THE DEVICE IS NOT EXPECTED TO RETURN. BACKGROUND: - PATIENT INFORMATION: NOT SPECIFIED. - LESION INFORMATION: PROXIMAL TO MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. - ASSOCIATED DEVICE: NOT SPECIFIED. - NO RETURNED DEVICE AND CASE IMAGE/CD WERE PROVIDED FOR ANALYSIS. - ADDITIONAL INFORMATION RECEIVED ON 23 APR 2025: Q1. PHYSICIAN FIRST AND LAST NAME? A1. (B)(6). Q2. WHY IS DEVICE NOT RETURNING? (IDENTIFY THE LOCATION E.G DISCARDED? RETAINED BY ACCOUNT?) A2. DISCARDED BY STAFF. Q3. ACCESS SITE? (FEMORAL, RADIAL, ET CETERA) A3. FEMORAL. Q4. % STENOSIS OF LAD? A4. 90%. Q5. GUIDING CATHETER/GUIDE WIRE? (BRAND NAME, TYPE, SIZE) A5. MEDTRONIC LAUNCHER GUIDE CATHETER, ASAHI FIELDER GUIDE WIRE. Q6. DID THE RUPTURE CAUSE ANY MATERIAL SEPARATION? A6. NO. Q7. IF SO, WAS EVERYTHING SUCCESSFULLY RETRIEVED? A7. N/A. Q8. WHAT TYPE OF DISSECTION OCCURRED? (A-F) A8. U

  Patient problems: Vascular Dissection

  MAUDE report 21974693 ↗
• MalfunctionMar 14, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  A SCOREFLEX NC SCORING BALLOON WAS USED TO TREAT A 95% STENOSED LESION IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. FOLLOWING A DIAGNOSTIC ANGIOGRAM, THE GUIDE CATHETER AND THE NON-CSI GUIDE WIRE WERE INSERTED. THE SCOREFLEX BALLOON WAS ADVANCED INTO THE MID LAD LESION. THE BALLOON BROKE WHILE ON THE DELIVERY WIRE. THE SCOREFLEX BALLOON WAS REMOVED INTACT WITHOUT AID OF ASSISTIVE DEVICES AND BALLOON ANGIOPLASTY WAS PERFORMED USING A COMPLIANT BALLOON. THE DEVICE IS EXPECTED TO RETURN. IT WAS REPORTED AS NO PATIENT COMPLICATIONS; PATIENT INFORMATION: 53 YEARS, MALE, 94KG; TREATED LESION INFORMATION: 95% STENOSED, MID LAD; PERCUTANEOUS ENTRY SITE: RIGHT RADIAL; ASSOCIATED PRODUCT INFORMATION: ASAHI MINAMO GUIDEWIRE, BOSTON SCIENTIFIC SYNERGY STENT 2.5MMX28MM, SAPPHIRE NC BALLOON 2.75MMX15MM, SHOCKWAVE BALLOON 3.0MMX12MM, SAPPHIRE NC BALLOON 3.0MMX18MM; MEDWATCH UF/IMPORTER REPORT NUMBER: (B)(4). NO CASE/IMAGE WAS PROVIDED FOR ANALYSIS. THE COMPLAINT PRODUCT, SCOREFLEX NC BALLOON CATHETER(2.5X10MM), WAS RETURNED FOR EVALUATION. MICROSCOPIC EXAMINATION REVEALED THAT THE TIP OF THE RETURNED BALLOON CATHETER WAS ELONGATED AND CUT LACERATED FROM RX PORT TO THE END OF THE TIP, EDGES O

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18900241 ↗
• InjuryNov 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SCORE FLEX BALLOON WAS ADVANCED OVER A GUIDE WIRE AND INFLATED SLOWLY TO 10 ATMOSPHERES (ATM) FOR ONE MINUTE, THEN SLOWLY DEFLATED. AN ANGIOGRAM WAS USED TO DETERMINE THE BALLOON NEEDED TO BE ADVANCED THREE TO FIVE MILLIMETERS. THE BALLOON WAS INFLATED SLOWLY TO 10 ATMOSPHERES FOR 30 SECONDS, AND THEN SLOWLY DEFLATED. THE PHYSICIAN ATTEMPTED TO REMOVE THE BALLOON, BUT THE WIRE WAS COMING BACK WITH THE BALLOON. THE BALLOON WAS UNABLE TO BE REMOVED WITHOUT THE WIRE, AS IT WAS WRAPPED AROUND THE BALLOON. ANOTHER ANGIOGRAM WAS OBSERVED, AND IT WAS NOTICED THERE WAS A DISSECTION ON THE DIAGONAL. A NON-CSI WIRE WAS ATTEMPTED TO BE USED, BUT CONTINUED GETTING CAUGHT IN THE DISSECTION. AFTER MULTIPLE ATTEMPTS, THE PHYSICIAN WAS ABLE TO RE-CROSS THE DIAGONAL WITH THE BALLOON AND A STENT WAS PLACED IN THE LESION AND DISSECTION.

  Patient problems: Vascular Dissection

  MAUDE report 18231379 ↗