SABER 48002510XRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 20705032069288), received between Oct 14, 2016 and Jun 3, 2022 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (3 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

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 3, 2022Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THERE WAS EXTRAVASATION OF CONTRAST THROUGH THE SABER 2.5MM 10CM BALLOON DUE TO A RUPTURE. THE CASE WAS COMPLETED WITH THE USE OF A NEW UNKNOWN CORDIS BALLOON. THE DEVICE WAS REMOVED INTACT (IN ONE PIECE) FROM THE PATIENT. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE RUPTURE OCCURRED IN THE VESSEL DURING THE ANGIOPLASTY OF THE ANTERIOR TIBIAL ARTERY. THE BALLOON DID NOT RUPTURE WHILE IN A STENT AS IT WAS ONLY A BALLOON ANGIOPLASTY. THE PRODUCT WAS STORED PROPERLY ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP, REMOVING THE BALLOON COVER, STYLET, OR ANY OF THE OTHER STERILE PACKAGING COMPONENTS. THERE WERE NO KINKS OR OTHER DAMAGES NOTED PRIOR TO INSERTING THE PRODUCT INTO THE PATIENT. THE DEVICE WAS PREPPED PER THE IFU. THE DEVICE WAS PREPPED NORMALLY AND WAS ABLE TO MAINTAIN NEGATIVE PRESSURE. THE SAME INFLATION DEVICE WAS USED SUCCESSFULLY WITH OTHER DEVICES DURING THE CASE. THERE WAS NO RESISTANCE/FRICTION NOTED WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE. THERE WAS NO RESISTANCE/FRICTION NOTED WHILE INSERTING THE BALLOON THROUGH THE GUIDE CATHETER. THERE WAS DIFFICULTY ADVANCING THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14595119 ↗
• MalfunctionMar 11, 2021Material Rupture; Material Rupture

  AS REPORTED, THE 2.5MM X 10CM X 150CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER (BC) BURST AT ONLY 4 ATMOSPHERES. A NEW BALLOON (UNKNOWN) WAS INSERTED AND INFLATED. THE PROCEDURE WAS CONTINUED. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS OPENED IN STERILE FIELD. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS AS IT WAS DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11462053 ↗
• MalfunctionFeb 1, 2021Inflation Problem; Inflation Problem

  AS REPORTED, A 5MM X 12MM X 80CM PALMAZ BLUE ON SLALOM BALLOON-EXPANDABLE STENT DELIVERY SYSTEM (SDS) WAS PREPPED PROPERLY AND THE STENT BALLOON WAS INFLATED TO 10 ATMOSPHERES (ATM); HOWEVER, THE STENT BALLOON DID NOT EXPAND AND STENT DID NOT DEPLOY. THE INDEFLATOR WAS REMOVED AND RE-PREPPED, AND INFLATION WAS ATTEMPTED ONCE AGAIN; STILL THE BALLOON WOULD NOT INFLATE. THE DEVICE WAS THEN REMOVED AND PLACED INSIDE A BIOHAZARD BAG. A NEW UNKNOWN DEVICE WAS USED TO FINISH THE TREATMENT. THERE WAS NO REPORTED PATIENT INJURY. THE OPERATOR WAS TRAINED TO USE THE DEVICE. THE DEVICE WAS STORED AS PER LABELING AND WAS OPENED IN A STERILE FIELD. THE DEVICE WAS STORED IN NORMAL CONDITIONS IN STOCK ROOM, FOR THREE MONTHS. THE DEVICE WAS STORED, HANDLED, AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DAMAGE TO THE DEVICE NOTICED PRIOR TO OPENING THE PACKAGE. THERE WAS NO DIFFICULTY REMOVING THE DEVICE FROM THE STERILE PACKAGING. THERE WERE NO KINKS OR OTHER DAMAGES NOTED PRIOR OR AFTER TO INSERTING THE PRODUCT INTO THE PATIENT. THE OTHER DEVICES USED WITH THE PRODUCT DID NOT KINK OR BEND AT ANY TIME. THERE WERE NO KINKS TO ANY PART OF THE DEVICE. THERE WAS NOTHING UNUSUAL NOTED AB

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11259054 ↗
• MalfunctionNov 12, 2020Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, A 2.5MM X 10CM X 150CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WAS INFLATED WITH INDEFLATOR TO 2 ATMOSPHERES (ATM); HOWEVER, THE BALLOON BURST. THEREFORE, IT WAS REMOVED IN ONE PIECE AND A SECOND SABER BALLOON WITH THE SAME SIZE WAS PREPPED ON STERILE FIELD AS PER THE INSTRUCTION FOR USE (IFU). THE BALLOON WAS ADVANCED OVER THE UNKNOWN WIRE TO THE AREA OF INTEREST AND INFLATED WITH INDEFLATOR AT 2 ATM; HOWEVER, THE BALLOON BURST. THE BALLOON WAS REMOVED INTACT AND ADDITIONAL UNKNOWN BALLOON CATHETER WAS USED TO COMPLETE THE CASE. THERE WAS NO REPORTED PATIENT INJURY. THE USER WAS TRAINED WITH THE DEVICE. THE PRODUCTS WERE STORED AS PER LABELING. THE DEVICES WERE OPENED IN A STERILE FIELD. INITIALLY, THE FIRST SABER BALLOON WAS PREPPED ON STERILE TABLE AS PER THE IFU. THE BALLOON WAS ADVANCED OVER THE WIRE TO AREA OF INTEREST. THE DEVICES WERE STORED AND HANDLED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE DEVICES WERE PREPPED NORMALLY BY MAINTAINING NEGATIVE PRESSURE. THERE WAS NO DIFFICULTY REMOVING THE PRODUCTS FROM THE HOOP OR REMOVING THE PROTECTIVE BALLOON COVERS. THERE WAS NO DIFFICULTY REMOVING THE STYLE OR ANY OF THE STERILE PACKA

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10831445 ↗
• MalfunctionNov 12, 2020Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, A 2.5MM X 10CM X 150CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WAS INFLATED WITH INDEFLATOR TO 2 ATMOSPHERES (ATM); HOWEVER, THE BALLOON BURST. THEREFORE, IT WAS REMOVED IN ONE PIECE AND A SECOND SABER BALLOON WITH THE SAME SIZE WAS PREPPED ON STERILE FIELD AS PER THE INSTRUCTION FOR USE (IFU). THE BALLOON WAS ADVANCED OVER THE UNKNOWN WIRE TO THE AREA OF INTEREST AND INFLATED WITH INDEFLATOR AT 2 ATM; HOWEVER, THE BALLOON BURST. THE BALLOON WAS REMOVED INTACT AND ADDITIONAL UNKNOWN BALLOON CATHETER WAS USED TO COMPLETE THE CASE. THERE WAS NO REPORTED PATIENT INJURY. THE USER WAS TRAINED WITH THE DEVICE. THE PRODUCTS WERE STORED AS PER LABELING. THE DEVICES WERE OPENED IN A STERILE FIELD. INITIALLY, THE FIRST SABER BALLOON WAS PREPPED ON STERILE TABLE AS PER THE IFU. THE BALLOON WAS ADVANCED OVER THE WIRE TO AREA OF INTEREST. THE DEVICES WERE STORED AND HANDLED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE DEVICES WERE PREPPED NORMALLY BY MAINTAINING NEGATIVE PRESSURE. THERE WAS NO DIFFICULTY REMOVING THE PRODUCTS FROM THE HOOP OR REMOVING THE PROTECTIVE BALLOON COVERS. THERE WAS NO DIFFICULTY REMOVING THE STYLE OR ANY OF THE STERILE PACKA

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10831421 ↗
• MalfunctionOct 14, 2016Leak/Splash; Leak/Splash

  WHEN TRYING TO INFLATE A SABER BALLOON CATHETER (2.5MM10CM 150) DURING AN ANGIOPLASTY PROCEDURE, IT WAS REPORTED THAT A PIN HOLE WAS NOTED IN THE BALLOON (LEAKAGE). THERE WAS NO DIFFICULTY REMOVING THE BALLOON CATHETER FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A NEW BALLOON AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORT OF PATIENT INJURY. THE PRODUCT WILL BE RETURNED FOR ANALYSIS. THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP OR DIFFICULTY REMOVING THE PROTECTIVE BALLOON COVER. THERE WAS NO DIFFICULTY REMOVING THE STYLET OR ANY OF THE STERILE PACKAGING COMPONENTS. THERE WERE NO KINKS OR OTHER DAMAGES NOTED PRIOR TO INSERTING THE PRODUCT INTO THE PATIENT. THE DEVICE PREPPED NORMALLY, MAINTAIN (B)(6) PRESSURE. THE CONTRAST MEDIA AND THE CONTRAST TO SALINE RATIO USED IS UNKNOWN. THE SAME INDEFLATOR WAS USED SUCCESSFULLY WITH OTHER DEVICES. THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE OR THROUGH THE GUIDE CATHETER. THE BALLOON CATHETER DID NOT KINK WHILE BEING USED. THERE IS NO INFORMATION REGARDING THE VESSEL/TARGET LESION OR ITS CHARACTERISTICS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6029821 ↗

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 · Terminated
  Cordis SABER PTA Balloon Dilation Catheter, 4F, REF 48004010X