SABER 48004002SRecalls & reported problems
Cordis US Corp. · SABER 4MM2CM 90 · Class 2
All models of SABER (51)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20705032069820), received between Feb 5, 2019 and Apr 9, 2019 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Burst Container or Vessel” (2 reports).
1 other recall cover devices cleared under the same FDA submission (K133843); 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 16, 2026.
Most reported problems
Device problems
- Burst Container or Vessel2
Patient problems
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 9, 2019Burst Container or Vessel; Burst Container or Vessel
AS REPORTED, A 4MMX2CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER (BC) WAS DELIVERED TO THE LESION AND INFLATED, HOWEVER IT RUPTURED WITHIN ITS RATED BURST PRESSURE. NO PATIENT INJURY WAS REPORTED. THIS WAS A SHUNT PTA CASE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8496791 ↗MalfunctionFeb 5, 2019Burst Container or Vessel; Burst Container or Vessel
DURING USE, IT WAS REPORTED THAT THE SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER (BC) WAS DELIVERED TO THE LESION AND INFLATED; HOWEVER IT RUPTURED AT EIGHT ATMOSPHERE (8 ATM). THERE WAS NO PATIENT INJURY. THEREFORE THE SABER PTA BALLOON WAS REPLACED WITH A SAME SIZE NEW COMPETITOR'S BALLOON CATHETER WHICH INFLATED. THE PROCEDURE WAS COMPLETED WITH A DRUG-COATED BALLOON. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS DUE TO INFECTIOUS DISEASE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8306592 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K133843. One submission often covers many models, so check the product and lot details in each record.
- Z-2235-2021 · Jul 19, 2021 · TerminatedCordis SABER PTA Balloon Dilation Catheter, 4F, REF 48004010X
Other Catheter, angioplasty, peripheral, transluminal devices
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- Coyote™ ES H74939135204010Boston Scientific Corporation · Catheter, angioplasty, peripheral, transluminal585 reports
- Coyote™ ES H74939135202010Boston Scientific Corporation · Catheter, angioplasty, peripheral, transluminal437 reports
- Coyote™ ES H74939135304010Boston Scientific Corporation · Catheter, angioplasty, peripheral, transluminal384 reports
- Coyote™ ES H74939135404010Boston Scientific Corporation · Catheter, angioplasty, peripheral, transluminal293 reports
- Coyote™ ES H74939134152010Boston Scientific Corporation · Catheter, angioplasty, peripheral, transluminal279 reports
- Coyote™ H74939185202210Boston Scientific Corporation · Catheter, angioplasty, peripheral, transluminal200 reports
- Coyote™ ES H74939135254010Boston Scientific Corporation · Catheter, angioplasty, peripheral, transluminal127 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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