Transpac 42587-05Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00840619033552), received between May 1, 2018 and May 1, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Defective Device” (1 report).

16 other recalls cover devices cleared under the same FDA submission (K932188); 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

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 1, 2018Device Inoperable; Defective Device; Material Deformation

  THE IR TEAM WAS PLANNING TO USE THIS MONITORING DEVICE THAT MEASURES BLOOD PRESSURE WITHIN THE FISTULA DURING A PROCEDURE. HOWEVER, THE TEAM ATTEMPTED TO ASSEMBLE THE PRODUCT THEY REALIZED ONE OF THE PIECES WAS BONDED TOGETHER. THE TEAM OBTAINED ANOTHER KIT, HOWEVER, UPON OPENING IT, THEY FOUND THAT THE PRODUCT WAS AGAIN BONDED. THE TEAM THEN PULLED ALL OF THE PRODUCT IN STOCK (7 PRODUCTS) AND FOUND THAT 6 OF THOSE PRODUCTS HAD THE SAME LOT NUMBER AS THE PRODUCT THAT WE DISCARDED AND 1 HAD A DIFFERENT LOT NUMBER. THE TEAM OPENED THE PRODUCT THAT HAD ITS OWN LOT NUMBER AND THAT PRODUCT WAS FINE AND WORKED AS IT SHOULD HAVE. UPON LATER INSPECTION OF THE OTHER REMAINING 6 WITH THE SAME "BAD" LOT NUMBERS WERE BONDED. THIS PRODUCT HAS SINCE BEEN TAKEN OUT OF CIRCULATION. THE LOT NUMBER FOR THE DEFECTIVE KITS IS 3598346. THE KIT THE TEAM ENDED UP USING IN THIS PROCEDURE THAT WAS NOT BONDED IS FROM LOT 3338172.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7475464 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K932188. One submission often covers many models, so check the product and lot details in each record.

• Z-2817-2016 · Aug 10, 2016 · Terminated
  Double Kit with SafeSet and 03mL Flush Device, Item No. 46080-37 Product Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transduc
• Z-2813-2016 · Aug 10, 2016 · Terminated
  Transpac IV Trifurcated Monitoring Kit with 84" SafeSet Reservoir, 03 ml Squeeze Flush and Needleless Valves, Item No. 42650-66 Product Usage: The Transpac Disposable Straight P
• Z-2821-2016 · Aug 10, 2016 · Terminated
  Pediatric Kit with 30mL Flush Device, Item No. 46099-10 Product Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that i
• Z-2823-2016 · Aug 10, 2016 · Terminated
  Monitoring Kit with TP4, 30 ml Squeeze Flush and Needleless Valve, Item No. 46103-22 Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular press
• Z-2825-2016 · Aug 10, 2016 · Terminated
  TP4 Kit with 10cc SafeSet Reservoir, Needleless Valve, Filter Millex and Admin Set, Item No. 46104-65 Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) is an e
• Z-2828-2016 · Aug 10, 2016 · Terminated
  Monitoring Kit with TP4, 30 ml Squeeze Flush Device, 10 cc Contamination Syringe and Needleless Valve, Item No. 46112-65 Product Usage: The Transpac Disposable Straight Pressure
• Z-2820-2016 · Aug 10, 2016 · Terminated
  Bifurcated SafeSet Kit with 03mL Flush Device, Item No. 46091-75 Product Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transduc
• Z-2815-2016 · Aug 10, 2016 · Terminated
  Monitoring Kit with 30mL Flush Device, Item No. 46076-15 Product Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that
• Z-2818-2016 · Aug 10, 2016 · Terminated
  Monitoring Kit with 03mL Flush Device, Item No. 46080-57 Product Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that
• Z-2822-2016 · Aug 10, 2016 · Terminated
  5 Port OFF Manifold with Transpac IV, Item No. 46100-29 Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interface
• Z-2811-2016 · Aug 10, 2016 · Terminated
  Transpac IV Monitoring Kit with SafeSet Reservoir and Blood Sampling Port, 24" Tubing, Disposable Transducer, 03 mL Squeeze Flush, Macrodrip (Patient Mount), Item No. 42648-06 P
• Z-2807-2016 · Aug 10, 2016 · Terminated
  Transpac IV Bifurcated Kit with SafeSet Reservoir, 03 ml Squeeze Flush and Needleless Valve, Item No. 42500-66 Usage: The Transpac Disposable Straight Pressure Transducer (DSPT
• Z-0619-05 · Nov 2, 2004 · Terminated
  Angiographic Syringe, 12 cc Thumb Ring with Rotator Non-Reservoir.
• Z-0617-05 · Nov 2, 2004 · Terminated
  Angiographic Syringe, 10 cc Thumb Ring with Rotator Reservoir.
• Z-0620-05 · Nov 2, 2004 · Terminated
  Angiographic Syringe, 12 cc Palm Pad with Rotator Reservoir.

…and 1 more.