Sleek PTA Dilatation Catheter 425-3004XRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00801741132414), received between Feb 21, 2018 and Jun 23, 2021 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (6 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 23, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING A PROCEDURE, THE BALLOON ALLEGEDLY RUPTURED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12049692 ↗
• InjuryFeb 11, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, THE SHAFT OF A 3MM X 40MM X 150CM SLEEK PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER SEPARATED WHILE INSIDE THE PATIENT. THE SEPARATED SEGMENT WAS REMOVED WITH A SNARE. THERE WAS NO REPORTED PATIENT INJURY. THE INTENDED PROCEDURE/TARGET LESION WAS THE ARTERY OF BELOW THE KNEE. THE ACCESS SITE LOCATION WAS THE FEMORAL ARTERY. THE LESION WAS SEVERELY CALCIFIED AND TORTUOUS. THE DEVICE WAS NOT USED FOR A CHRONIC TOTAL OCCLUSION (TOTAL OCCLUSION >3 MONTHS). THE DEVICE WAS NOT RESTERILIZED. THERE WERE NO ANOMALIES NOTED WHEN REMOVED FROM THE PACKAGE. THERE WERE NO ANOMALIES NOTED DURING PREP. THE PRODUCT LOOKED NORMAL WHEN REMOVED FROM ITS PACKAGING. THE DEVICE WAS PREPPED NORMALLY (I.E. MAINTAIN NEGATIVE PRESSURE). THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP, THE PROTECTIVE BALLOON COVER, OR THE STYLET OR ANY OF THE STERILE PACKAGING COMPONENTS. THERE WERE NO KINKS NOR OTHER DAMAGES NOTED PRIOR TO INSERTING THE PRODUCT INTO THE PATIENT. AN INFLATION DEVICE WAS USED. THE SAME INDEFLATOR WAS USED SUCCESSFULLY WITH OTHER DEVICES. THE DEVICE DID NOT HAVE TO PASS THROUGH A PREVIOUSLY PLACED STENT. THE BALLOON WAS INFLATED 3 TIMES. THE PRODUCT WAS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11313791 ↗
• MalfunctionJan 19, 2021Break; Break

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE SHAFT OF THE DEVICE ALLEGEDLY BROKE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11192352 ↗
• MalfunctionOct 11, 2019Material Rupture; Material Rupture

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 425-3004X PTA DILATATION CATHETER ALLEGEDLY EXPERIENCED MATERIAL RUPTURE. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THIS MALFUNCTION DID INVOLVE A PATIENT WITH NO PATIENT INJURY. THE PATIENT AGE, GENDER, AND WEIGHT WERE NOT REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9182923 ↗
• MalfunctionOct 11, 2019Break; Failure to Advance; Material Deformation; Break; Failure to Advance; Material Deformation

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 425-3004X PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED FAILURE TO ADVANCE, MATERIAL DEFORMATION, AND BREAK. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE MALFUNCTION INVOLVED A PATIENT WITH NO KNOWN IMPACT TO THE PATIENT. THE PATIENT¿S AGE, WEIGHT, AND GENDER WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9182919 ↗
• MalfunctionJul 11, 2019Material Rupture; Material Rupture

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 425-3004X RX PTA CATHETER ALLEGEDLY EXPERIENCED A MATERIAL RUPTURE. THIS INFORMATION WAS RECEIVED FROM A SINGLE SOURCE. THE MALFUNCTION INVOLVED A PATIENT WITH NO CONSEQUENCE. THE PATIENT¿S AGE, WEIGHT, AND SEX WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8783267 ↗
• MalfunctionApr 19, 2019Material Rupture; Material Rupture

  THIS REPORT SUMMARIZES ONE MALFUNCTION EVENT. A REVIEW OF THE EVENTS INDICATED THAT MODEL 425-3004X PTA DILATATION CATHETER ALLEGEDLY RUPTURED. THIS REPORT WAS RECEIVED FROM ONE SOURCE. THE DEVICE WAS USED IN THE PATIENT, WITH NO REPORTED PATIENT INJURY. THE PATIENT'S AGE, WEIGHT, AND GENDER WAS NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8532927 ↗
• MalfunctionOct 2, 2018Partial Blockage; Break; Material Rupture; Detachment of Device or Device Component; Partial Blockage; Break; Material Rupture; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE THE GUIDEWIRE LUMEN WAS OBSTRUCTED, AND THE GUIDEWIRE WAS ALLEGEDLY UNABLE TO LOAD THROUGH THE PTA DILATATION CATHETER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7926736 ↗
• MalfunctionFeb 21, 2018Material Rupture; Failure to Advance; Material Rupture; Failure to Advance

  IT WAS REPORTED THAT THE PTA BALLOON CATHETER ALLEGEDLY FAILED TO CROSS THE STENOSIS. IT WAS FURTHER REPORTED THAT THE BALLOON ALLEGEDLY RUPTURED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7287763 ↗