AngioSculpt PTCA RX Scoring Balloon Catheter 2200-3510Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00813132021238), received between Dec 31, 2018 and Jul 28, 2021 — classified as 3 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (4 reports).

3 other recalls cover devices cleared under the same FDA submission (P050018); 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 18, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 28, 2021Material Rupture; Material Rupture

  THE ANGIOSCULPT DEVICE WAS USED TO TREAT THE MID LAD. DURING THE SECOND INFLATION AT 6 ATM FOR 10 SECONDS, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH A NON-ANGIOSCULPT DEVICE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12243372 ↗
• MalfunctionJun 10, 2021Material Rupture; Material Rupture

  THE ANGIOSCULPT DEVICE WAS USED TO TREAT THE SEVERELY CALCIFIED PROXIMAL ILIAC ARTERY. AFTER THE 3RD INFLATION AT 16 ATM FOR 10 SECONDS, THE BALLOON RUPTURED. A NEW ANGIOSCULPT DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11980226 ↗
• MalfunctionMar 23, 2021Material Rupture; Material Rupture

  THE ANGIOSCULPT DEVICE WAS USED TO TREAT A SEVERELY CALCIFIED AND SEVERELY TORTUOUS MID LAD. DURING THE 4TH INFLATION AT 12 ATM FOR 5 SECONDS, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH A NEW ANGIOSCULPT DEVICE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11554916 ↗
• MalfunctionJan 13, 2021Material Rupture; Material Rupture

  THE ANGIOSCULPT DEVICE WAS USED TO TREAT A MODERATELY CALCIFIED PROXIMAL LAD. DURING THE SECOND INFLATION AT 4 ATM FOR 10SEC, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETE WITH A NEW ANGIOSCULPT DEVICE. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11167694 ↗
• InjuryNov 6, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  THE ANGIOSCULPT DEVICE WAS DELIVERED TO THE LESION WITH NO RESISTANCE. USING AN ENDOFLATOR, NEGATIVED AIR WAS APPLIED AND BLOOD WAS OBSERVED ON THE ENDOFLATOR. DURING REMOVAL, THE PROXIMAL SHAFT SEPARATED INSIDE THE GUIDE CATHETER; THEREFORE, THE DEVICE WAS REMOVED AS A UNIT. REWIRING OF THE LESION WAS REQUIRED TO COMPLETE THE PROCEDURE WITH A NEW ANGIOSCULPT DEVICE. NO PATIENT INJURY REPORTED.

  Patient problems: Injury

  MAUDE report 10801170 ↗
• MalfunctionMar 20, 2020Break; Break

  DURING INSERTION OF THE ANGIOSCULPT DEVICE INTO THE GUIDE CATHETER, RESISTANCE WAS FELT AND THE PROXIMAL SHAFT BUCKLED AND KINKED. AS THE PHYSICIAN STRAIGHTENED OUT THE KINK, THE SHAFT BROKE IN HIS HANDS. THE DISTAL PORTION OF THE DEVICE WAS STILL IN THE GUIDE CATHETER; HOWEVER, THE SEPARATED PORTION OCCURRED OUTSIDE OF THE PATIENT'S BODY. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9863084 ↗
• InjurySep 16, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  FIRST, PATIENT WAS TREATED WITH A 3.0 AND 3.5 NC BALLOON WITH INADEQUATE RESULTS. NEXT, A 3.5 ANGIOSCULPT WAS INTRODUCED WITHOUT RESISTANCE. THE BALLOON WAS DILATED, BUT COULD NOT BE REMOVED FROM THE WINGED BALLOON. THE GUIDE WIRE SUPPORT WAS NOT GOOD DUE TO THE TAVR. PHYSICIAN WAS UNABLE TO DEEP-THROAT THE GUIDE OR USE A TELESCOPING GUIDE. PHYSICIAN THEN BALLOONED MULTIPLE TIMES WITH A BUDDY WIRE AND A NC BALLOON ALONG SIDE THE ANGIOSCULPT, BUT UNABLE TO LOOSEN IT. OVER AN HOUR LATER, THE PHYSICIAN TRIED TUGGING HARD ON THE ANGIOSCULPT TO RELEASE, BUT THE CATHETER FELL APART. A SNARE WAS USED WITHOUT SUCCESS. SINCE THE PATIENT HAD SIGNIFICANT COMORBIDITIES AND THE FACT THE LAD AND RCA WERE PROTECTED, THE PHYSICIAN DID NOT TAKE HIM TO THE OR AND THE PATIENT ELECTED NOT TO HAVE SURGERY. PATIENT WAS TREATED WITH COUMADIN AND PLAVIX AND IS DOING WELL. PHYSICIAN COMMENTED THAT THE ANGIOSCULPT SCORING ELEMENT WAS PROBABLY STUCK IN THE PREVIOUSLY PLACED LCX STENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9074035 ↗
• InjuryAug 8, 2019Difficult to Remove; Difficult to Remove

  PATIENT HAD PREVIOUSLY PLACED STENTS IN LEFT MAIN AND LAD WITH SIGNIFICANT IN-STENT RESTENOSIS. THE VESSEL WAS HIGHLY CALCIFIED, WITH MODERATE TORTUOSITY. THE PHYSICIAN DECIDED TO TREAT WITH A 3.5 MM X 10 MM ANGIOSCULPT DEVICE. AFTER INFLATING IT TWICE, THE BALLOON COULD NOT BE REMOVED AND BELIEVED IT GOT STUCK ON A SHARP CALCIUM CHUNK. THE PHYSICIAN WAS ABLE TO GET A GUIDELINER TO ABUT THE ANGIOSCULPT SCORING ELEMENT AND GET A 3.5 MM X 30 MM NON-COMPLIANT BALLOON DISTAL TO THE ANGIOSCULPT BALLOON ON A BUDDY WIRE TO PULL THE BALLOON BACK INTO THE GUIDELINER. THE PATIENT EXPERIENCED MILD ANGINA DURING REMOVAL, BUT OTHERWISE WAS DISCHARGED THE FOLLOWING DAY WITH GOOD FLOW AND NO COMPLICATIONS.

  Patient problems: Angina

  MAUDE report 8874027 ↗
• MalfunctionDec 31, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  DURING DELIVERY TO THE LESION, PRIOR TO BALLOON INFLATION, THE ANGIOSCULPT DEVICE SEPARATED AT THE PROXIMAL SHAFT (OUTSIDE OF BODY). THE BALLOON WAS ABLE TO BE REMOVED WITH NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8206988 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P050018. One submission often covers many models, so check the product and lot details in each record.

• Z-0576-2020 · Dec 7, 2018 · Terminated
  Spectranetics AngioSculpt PTCA Scoring Balloon Catheter, balloon outer diameter 2.5mm, balloon length 15mm, REF 2027-2515, Sterile, Rx. The firm name on the label is Spectranetics
• Z-2218-2010 · Dec 4, 2009 · Terminated
  AngioSculpt Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter, cutting/scoring, Easy Exchange (EX) delivery system, Manufactured by AngioScore, Fremont, CA. Catheter
• Z-0591-2008 · Nov 13, 2007 · Terminated
  AngioSculpt PTCA Scoring Balloon Catheter, Catalog (REF) Number: 2027-2510, size 2.5mm x 10 mm, AngioScore, Inc., Fremont, CA.