Sleek OTW PTA Dilatation Catheter 426-5010XRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741133992), received between Jan 6, 2021 and Dec 14, 2023 — classified as 1 injury, 2 malfunctions.

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

• MalfunctionDec 14, 2023Break; Deflation Problem; Difficult to Remove; Device-Device Incompatibility; Material Deformation; Break; Deflation Problem; Difficult to Remove; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY FAILED TO DEFLATE. IT WAS FURTHER REPORTED THAT THE PTA BALLOON WAS ALLEGEDLY DIFFICULT TO BE REMOVED FROM THE GUIDEWIRE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18325320 ↗
• InjuryJan 6, 2021Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  AS THE BALLOON OF A 5MM X 10CM X 150CM SLEEK OVER-THE-WIRE (OTW) PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER (BC) WAS BEING WITHDRAWN FROM THE PATIENT, IT GOT CAUGHT UP ON THE TIP OF THE 6F NON-CORDIS SHEATH AND WASN¿T ABLE TO BE REMOVED. AS FURTHER ATTEMPTS WERE MADE TO WITHDRAW THE SLEEK BALLOON, THE ENTIRE BALLOON SEPARATED FROM THE SHAFT AND REMAINED IN THE PATIENT¿S TIBIAL ARTERY. THE REMAINING SHAFT WAS REMOVED OVER THE WIRE AND THE PATIENT WAS SENT TO SURGERY AFTER FAILED ATTEMPT AT SNARING THE BALLOON. THE BALLOON WAS REMOVED BY A VASCULAR SURGEON IN THE OPERATION ROOM (OR) BY CUTDOWN AFTER BEING TRANSPORTED TO THE HOSPITAL. THE PATIENT IS DOING WELL WITH NO ISSUES. THE DEVICE WAS STORED AND HANDLED AS PER THE INSTRUCTION FOR USE (IFU). THERE WAS NO DAMAGE NOTED TO THE PACKAGING OF THE DEVICE. THERE WERE NO ANOMALIES NOTED WHEN REMOVED FROM THE PACKAGE. THE DEVICE WAS OPENED IN STERILE FIELD. THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP, THE PROTECTIVE BALLOON COVER, STYLET OR ANY OF THE STERILE PACKAGING COMPONENTS. THERE WERE NO KINKS OR OTHER DAMAGES NOTED PRIOR TO INSERTING THE PRODUCT THE PRODUCT INTO THE PATIENT. THE INTENDED PROCED

  Patient problems: Insufficient Information

  MAUDE report 11125058 ↗
• MalfunctionJan 6, 2021Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PTA PROCEDURE WITH THE INTENDED TREATMENT SITE TO BE THE SFA FROM PEDAL ACCESS, THE LESION WAS SEVERELY CALCIFIED, THE VESSEL WAS MODERATELY TORTOUS IN NATURE AND THE PATIENT HAD 99% STENOSIS. THE DEVICE WAS ALLEGEDLY DIFFICULT TO BE REMOVED. IT WAS FURTHER REPORTED THAT THE DEVICE SEPARATED FROM THE SHAFT AND REMAINED INSIDE THE TIBIAL ARTERY PATIENT. THE DETACHED PIECE WAS REMOVED AFTER FURTHER INTERVENTION. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11122266 ↗