SABER 48007002SRecalls & reported problems
Cordis US Corp. · SABER 7MM2CM 90 · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20705032068823), received between Feb 18, 2019 and Feb 18, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Leak/Splash” (1 report).
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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Leak/Splash1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 18, 2019Leak/Splash; Leak/Splash
AS REPORTED, THIS WAS A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CASE, A SABER PTA 7MM2CM 90 WAS INFLATED OUTSIDE OF THE PATIENT; HOWEVER, IT WAS CONFIRMED THAT THE SABER PTA HAD A PINHOLE. THERE WERE NO REPORTED PATIENT INJURIES. THE SABER PTA BALLOON WAS REPLACED WITH A NEW BALLOON CATHETER AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE DEVICE WAS STORED ON A SHELF WITH OTHER DEVICES. THE DEVICE WAS PREPPED PER THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP OR NO DIFFICULTY REMOVING THE PROTECTIVE BALLOON COVER. THERE WAS NO DIFFICULTY REMOVING THE STYLET OR ANY OF THE STERILE PACKAGING COMPONENTS. THE BALLOON CATHETER DID NOT KINK WHILE BEING USED. THE LEAKAGE/PINHOLE WAS OBSERVED ON THE BALLOON. THERE WAS NO UNUSUAL FORCE USED AT ANY TIME.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8348158 ↗
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
- Coyote™ ES H74939135152010Boston Scientific Corporation · Catheter, angioplasty, peripheral, transluminal879 reports
- 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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