Prytime Medical Devices Inc. ER7232PLUSRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00850001105057), received between Sep 3, 2024 and Sep 3, 2024 — classified as 1 injury.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (1 report).

1 other recall cover devices cleared under the same FDA submission (K193440); 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 18, 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.

• InjurySep 3, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  PLACENTA PRAEVIA TOTALIS PERCRETA PATIENT WAS ORIGINALLY PLANNED FOR A C-SECTION WITH ELECTIVE USE OF THE REBOA THROUGH A SPECIAL TEAM EXPERIENCED IN ENDOVASCULAR PROCEDURES. BLEEDING AND WORSENING OF THE CHILD'S PERFUSION LED TO AN UNPLANNED, URGENT C-SECTION WITH BLOOD LOSS GREATER THAN 2.5 LITERS. THE CONSULTANT IN CHARGE DECIDED TO USE THE ER-REBOA PLUS CATHETER. THE INITIAL PLACEMENT OF THE 7FR SHEATH WAS UNEVENTFUL. THE CONSULTANT HAD A FORMAL TRAINING SESSION FOR REBOA, BUT IN THIS CASE HE DIDN'T USE A DISTAL BP MEASUREMENT NOR DID HE USE THE RECOMMENDED OCCLUSION VOLUME (2CC). HE USED 20CC FOR INFLATING THE BALLOON. AFTER OCCLUDING THE AORTA IN ZONE III, IT LED TO GOOD OPERATION CONDITIONS FOR THE OBS. AFTER FINISHING THE OPERATION, THE TEAM TRIED TO DEFLATE THE BALLOON, WHICH WAS FOLLOWED WITH A PROFOUND HEMODYNAMICALLY INSTABLE SITUATION. THE REASON WAS A RUPTURED RETROPERITONEAL AORTA (LESION 4CM VENTRALLY, AT THE BALLOON POSITION). AORTA WAS SUTURED AND A PATCH WAS USED. AS OF (B)(6) 2024, PATIENT WAS AT HOME AND IN GOOD HEALTH.

  Patient problems: Perforation of Vessels

  MAUDE report 20131170 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K193440. One submission often covers many models, so check the product and lot details in each record.

• Z-0716-2021 · Oct 29, 2020 · Terminated
  PryTime Medical - ER-Reboa Plus Catheter, Ref: ER7232PLUS, Guidewire Free, Compatabel with 7Fr introducer Sheaths, Arterial Line, Rx Only, UDI: (01) 0 0850001 10505 7 - Product Usa