PeriVac™ Kit M00443050Recalls & reported problems
Boston Scientific Corporation · Pericardiocentesis Kit · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729744856), received between Jul 25, 2018 and Mar 2, 2022 — classified as 1 injury, 3 malfunctions.
The most frequently reported specific device problem is “Defective Device” (1 report).
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
- Defective Device1
- Device Markings/Labelling Problem1
- Insufficient Device Problem Information1
- Obstruction of Flow1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Complaint, Ill-Defined1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 2, 2022Defective Device; Defective Device
IT WAS REPORTED THAT DURING PREPARATION, THE PERIVAC KIT WAS UNABLE TO BE FLUSHED. A DIFFERENT KIT WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13655660 ↗MalfunctionMar 30, 2021Device Markings/Labelling Problem; Device Markings/Labelling Problem
IT WAS REPORTED THAT A PACKING ERROR OCCURRED WITH A PERIVAC PERICARDIOCENTESIS KIT. INSTEAD OF A PERICARDIAL PUNCTURE SET, A PLEURAL PUNCTURE SET WAS INCLUDED. THE PROCEDURE WAS COMPLETED WITH ANOTHER PERIVAC KIT AND NO PATIENT COMPLICATIONS OCCURRED. THE DEVICE WAS DISPOSED OF AND THEREFORE WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11591520 ↗MalfunctionJul 30, 2019Obstruction of Flow; Obstruction of Flow
IT WAS REPORTED THAT A OCCLUSION OCCURRED. A PERIVAC PERICARDIOCENTESIS KIT WAS SELECTED FOR A PERICARDIOCENTESIS PROCEDURE. DURING THE PROCEDURE IT WAS NOTICED THAT THE CATHETER WAS OCCLUDED THE "DISTAL TIP IS NOT WELL SUCKED BECAUSE THE HOLE IS REPLACED". THE PROCEDURE WAS COMPLETED WITH NO PATIENTS COMPLICATIONS BEING REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8842658 ↗InjuryJul 25, 2018Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT DURING AN PROCEDURE INVOLVING A PERIVAC PERICARDIOCENTESIS KIT, THE PATIENT EXPERIENCED COMPLICATIONS (UNSPECIFIED). THE PHYSICIAN WAS UNSURE IF THE COMPLICATIONS WERE RELATED TO THE DEVICE OR THE PROCEDURE. THE DEVICE WAS DISCARDED AND THE PHYSICIAN DECLINED FURTHER FOLLOW-UP.
Patient problems: Complaint, Ill-Defined
MAUDE report 7717705 ↗
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- ENROUTE .014" Guidewire 11686-01Silk Road Medical, Inc. · Wire, Guide, Catheter2 deaths228 reports
- ARROW IPN035915Teleflex Incorporated · WIRE, GUIDE, CATHETER217 reports
- OmniWire Pressure guide wire 89185Philips Image Guided Therapy Corporation · Wire, Guide, Catheter1 recall1 death160 reports
- ARROW IPN055780Teleflex Incorporated · Wire, guide, catheter4 recalls0 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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