PENTAX OE-A52Recalls & reported problems
Hoya Corporation · PENTAX Balloon OE-A52 · Class 2
Quick summary
This PENTAX balloon kit is an accessory used with bronchoscopes. The 47 reports mostly describe packaging and shipping problems — kits arriving in non-sterile condition or past their expiration date. There are 44 reports of injury and 3 of malfunction, with no deaths reported, and none mention any harm to patients. No recalls name this device, and there were no reports in either of the past two 12-month periods.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 47
- Deaths reported
- 0
- Injuries reported
- 44
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 47 adverse event reports that list this exact device (DI 04961333146062), received between Sep 16, 2024 and Sep 18, 2024 — classified as 44 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Delivered as Unsterile Product” (25 reports).
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.
Reports received per month
Most reported problems
Device problems
- Delivered as Unsterile Product25
- Manufacturing, Packaging or Shipping Problem22
Patient problems
- No Clinical Signs, Symptoms or Conditions47
Recent adverse event reports
The 25 most recent of 47 reports, in the reporter's own words as published by the FDA.
InjurySep 18, 2024Delivered as Unsterile Product; Delivered as Unsterile Product
THIS FOLLOW UP REPORT FOR MDR 9610877-2024-00108 SERVES AS A RETRACTION OF THE INITIAL REPORT INVALIDATING THE SEPTEMBER 18, 2024 INITIAL SUBMISSION. REFER TO H11 FOR ADDITIONAL DETAILS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20252853 ↗InjurySep 18, 2024Delivered as Unsterile Product; Delivered as Unsterile Product
THIS FOLLOW UP REPORT FOR MDR 9610877-2024-00102 SERVES AS A RETRACTION OF THE INITIAL REPORT INVALIDATING THE SEPTEMBER 18, 2024, INITIAL SUBMISSION. REFER TO H11 FOR ADDITIONAL DETAILS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20252850 ↗InjurySep 18, 2024Delivered as Unsterile Product; Delivered as Unsterile Product
THIS FOLLOW UP REPORT FOR MDR 9610877-2024-00098 SERVES AS A RETRACTION OF THE INITIAL REPORT INVALIDATING THE SEPTEMBER 18, 2024 INITIAL SUBMISSION. REFER TO H11 FOR ADDITIONAL DETAILS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20252835 ↗MalfunctionSep 18, 2024Delivered as Unsterile Product; Delivered as Unsterile Product
ON 30-AUG-2024, PENTAX MEDICAL BECAME AWARE OF OF AN INITIAL REPORT OF SHIPMENT OF THREE(3) EXPIRED BALLOON KITS RECEIVED AT THE USER FACILITY: #1- CONTAINING ONE(1) BOX WAS THAT WAS SHIPPED TO THE USER FACILITY ON 24-JUN-2024, WITH AN EXPIRATION DATE OF 30-JUN-2024. #2- CONTAINING TWO(2) BOXES THAT WERE SHIPPED TO THE USER FACILITY ON 14-AUG-2024 WITH THE SAME EXPIRATION DATE (30-JUN-2024). THERE WAS NO REPORT OF PATIENT HARM. DESCRIPTION OF ANY ACTIONS TAKEN: IDENTIFIED THE ORDERS PER BELOW: BOX NUMBER 1 WAS SHIPPED ON 31-JUN-2024. BOX NUMBER 2 WAS SHIPPED ON 13-AUG-2024. THIS EVENT MEETS THE REQUIREMENTS FOR FDA REPORTABILITY; HOWEVER, SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, MANUFACTURER OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT..
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20252820 ↗InjurySep 18, 2024Delivered as Unsterile Product; Delivered as Unsterile Product
THIS FOLLOW UP REPORT FOR MDR 9610877-2024-00110 SERVES AS A RETRACTION OF THE INITIAL REPORT INVALIDATING THE SEPTEMBER 18, 2024, INITIAL SUBMISSION. REFER TO H11 FOR ADDITIONAL DETAILS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20252796 ↗InjurySep 18, 2024Delivered as Unsterile Product; Delivered as Unsterile Product
THIS FOLLOW UP REPORT FOR MDR 9610877-2024-00100 SERVES AS A RETRACTION OF THE INITIAL REPORT INVALIDATING THE SEPTEMBER 18, 2024, INITIAL SUBMISSION. REFER TO H11 FOR ADDITIONAL DETAILS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20252793 ↗InjurySep 18, 2024Delivered as Unsterile Product; Delivered as Unsterile Product
ON 30-AUG-2024, PENTAX MEDICAL BECAME AWARE OF OF AN INITIAL REPORT OF SHIPMENT OF THREE(3) EXPIRED BALLOON KITS RECEIVED AT THE USER FACILITY: #1- CONTAINING ONE(1) BOX WAS THAT WAS SHIPPED TO THE USER FACILITY ON 24-JUN-2024, WITH AN EXPIRATION DATE OF 30-JUN-2024. #2- CONTAINING TWO(2) BOXES THAT WERE SHIPPED TO THE USER FACILITY ON 14-AUG-2024 WITH THE SAME EXPIRATION DATE (30-JUN-2024). THERE WAS NO REPORT OF PATIENT HARM. DESCRIPTION OF ANY ACTIONS TAKEN: IDENTIFIED THE ORDERS PER BELOW: BOX NUMBER 1 WAS SHIPPED ON 31-JUN-2024. BOX NUMBER 2 WAS SHIPPED ON 13-AUG-2024. THIS EVENT MEETS THE REQUIREMENTS FOR FDA REPORTABILITY; HOWEVER, SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, MANUFACTURER OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT..
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20252786 ↗InjurySep 18, 2024Delivered as Unsterile Product; Delivered as Unsterile Product
THIS FOLLOW UP REPORT FOR MDR 9610877-2024-00112 SERVES AS A RETRACTION OF THE INITIAL REPORT INVALIDATING THE SEPTEMBER 18, 2024 INITIAL SUBMISSION. REFER TO H11 FOR ADDITIONAL DETAILS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20252768 ↗InjurySep 18, 2024Delivered as Unsterile Product; Delivered as Unsterile Product
THIS FOLLOW UP REPORT FOR MDR 9610877-2024-00105 SERVES AS A RETRACTION OF THE INITIAL REPORT INVALIDATING THE SEPTEMBER 18, 2024 INITIAL SUBMISSION. REFER TO H11 FOR ADDITIONAL DETAILS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20252762 ↗InjurySep 18, 2024Delivered as Unsterile Product; Delivered as Unsterile Product
THIS FOLLOW UP REPORT FOR MDR 9610877-2024-00114 SERVES AS A RETRACTION OF THE INITIAL REPORT INVALIDATING THE SEPTEMBER 18, 2024, INITIAL SUBMISSION. REFER TO H11 FOR ADDITIONAL DETAILS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20252685 ↗InjurySep 18, 2024Delivered as Unsterile Product; Delivered as Unsterile Product
THIS FOLLOW UP REPORT FOR MDR 9610877-2024-00111 SERVES AS A RETRACTION OF THE INITIAL REPORT INVALIDATING THE SEPTEMBER 18, 2024, INITIAL SUBMISSION. REFER TO H11 FOR ADDITIONAL DETAILS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20252665 ↗InjurySep 18, 2024Delivered as Unsterile Product; Delivered as Unsterile Product
THIS FOLLOW UP REPORT FOR MDR 9610877-2024-00113 SERVES AS A RETRACTION OF THE INITIAL REPORT INVALIDATING THE SEPTEMBER 18, 2024 INITIAL SUBMISSION. REFER TO H11 FOR ADDITIONAL DETAILS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20252663 ↗InjurySep 18, 2024Delivered as Unsterile Product; Delivered as Unsterile Product
THIS FOLLOW UP REPORT FOR MDR 9610877-2024-00107 SERVES AS A RETRACTION OF THE INITIAL REPORT INVALIDATING THE SEPTEMBER 18, 2024 INITIAL SUBMISSION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20252661 ↗InjurySep 18, 2024Delivered as Unsterile Product; Delivered as Unsterile Product
THIS FOLLOW UP REPORT FOR MDR SERVES AS A RETRACTION OF THE INITIAL REPORT INVALIDATING THE SEPTEMBER 18, 2024 INITIAL SUBMISSION. REFER TO H11 FOR ADDITIONAL DETAILS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20252656 ↗InjurySep 18, 2024Delivered as Unsterile Product; Delivered as Unsterile Product
THIS FOLLOW UP REPORT FOR MDR 9610877-2024-00106 SERVES AS A RETRACTION OF THE INITIAL REPORT INVALIDATING THE (B)(6) 2024 INITIAL SUBMISSION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20252654 ↗InjurySep 18, 2024Delivered as Unsterile Product; Delivered as Unsterile Product
THIS FOLLOW UP REPORT FOR MDR SERVES AS A RETRACTION OF THE INITIAL REPORT INVALIDATING THE SEPTEMBER 18, 2024 INITIAL SUBMISSION. REFER TO H11 FOR ADDITIONAL DETAILS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20252653 ↗InjurySep 18, 2024Delivered as Unsterile Product; Delivered as Unsterile Product
THIS FOLLOW UP REPORT FOR MDR 9610877-2024-00103 SERVES AS A RETRACTION OF THE INITIAL REPORT INVALIDATING THE SEPTEMBER 18, 2024 INITIAL SUBMISSION. REFER TO H11 FOR ADDITIONAL DETAILS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20252651 ↗InjurySep 18, 2024Delivered as Unsterile Product; Delivered as Unsterile Product
ON 30-AUG-2024, PENTAX MEDICAL BECAME AWARE OF AN INITIAL REPORT OF SHIPMENT OF THREE (3) EXPIRED BALLOON KITS RECEIVED AT THE USER FACILITY: #1- CONTAINING ONE (1) BOX WAS THAT WAS SHIPPED TO THE USER FACILITY ON 24-JUN-2024, WITH AN EXPIRATION DATE OF 30-JUN-2024. #2- CONTAINING TWO (2) BOXES THAT WERE SHIPPED TO THE USER FACILITY ON 14-AUG-2024 WITH THE SAME EXPIRATION DATE (30-JUN-2024). THERE WAS NO REPORT OF PATIENT HARM. DESCRIPTION OF ANY ACTIONS TAKEN: IDENTIFIED THE ORDERS PER BELOW: BOX NUMBER 1 WAS SHIPPED ON 31-JUN-2024. BOX NUMBER 2 WAS SHIPPED ON 13-AUG-2024. THIS EVENT MEETS THE REQUIREMENTS FOR FDA REPORTABILITY; HOWEVER, SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, MANUFACTURER OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20252647 ↗InjurySep 18, 2024Delivered as Unsterile Product; Delivered as Unsterile Product
ON 30-AUG-2024, PENTAX MEDICAL BECAME AWARE OF AN INITIAL REPORT OF SHIPMENT OF THREE (3) EXPIRED BALLOON KITS RECEIVED AT THE USER FACILITY: #1- CONTAINING ONE (1) BOX WAS THAT WAS SHIPPED TO THE USER FACILITY ON 24-JUN-2024, WITH AN EXPIRATION DATE OF 30-JUN-2024. #2- CONTAINING TWO (2) BOXES THAT WERE SHIPPED TO THE USER FACILITY ON 14-AUG-2024 WITH THE SAME EXPIRATION DATE (30-JUN-2024). THERE WAS NO REPORT OF PATIENT HARM. DESCRIPTION OF ANY ACTIONS TAKEN: IDENTIFIED THE ORDERS PER BELOW: BOX NUMBER 1 WAS SHIPPED ON 31-JUN-2024. BOX NUMBER 2 WAS SHIPPED ON 13-AUG-2024. THIS EVENT MEETS THE REQUIREMENTS FOR FDA REPORTABILITY; HOWEVER, SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, MANUFACTURER OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20252637 ↗InjurySep 18, 2024Delivered as Unsterile Product; Delivered as Unsterile Product
THIS FOLLOW UP REPORT FOR MDR 9610877-2024-00097 SERVES AS A RETRACTION OF THE INITIAL REPORT INVALIDATING THE SEPTEMBER 18, 2024 INITIAL SUBMISSION. REFER TO H11 FOR ADDITIONAL DETAILS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20252635 ↗InjurySep 18, 2024Delivered as Unsterile Product; Delivered as Unsterile Product
THIS FOLLOW UP REPORT FOR MDR 9610877-2024-00096 SERVES AS A RETRACTION OF THE INITIAL REPORT INVALIDATING THE SEPTEMBER 18, 2024, INITIAL SUBMISSION. REFER TO H11 FOR ADDITIONAL DETAILS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20252633 ↗InjurySep 18, 2024Delivered as Unsterile Product; Delivered as Unsterile Product
ON 30-AUG-2024, PENTAX MEDICAL BECAME AWARE OF AN INITIAL REPORT OF SHIPMENT OF THREE (3) EXPIRED BALLOON KITS RECEIVED AT THE USER FACILITY: #1- CONTAINING ONE (1) BOX WAS THAT WAS SHIPPED TO THE USER FACILITY ON 24-JUN-2024, WITH AN EXPIRATION DATE OF 30-JUN-2024. #2- CONTAINING TWO (2) BOXES THAT WERE SHIPPED TO THE USER FACILITY ON 14-AUG-2024 WITH THE SAME EXPIRATION DATE (30-JUN-2024). THERE WAS NO REPORT OF PATIENT HARM. DESCRIPTION OF ANY ACTIONS TAKEN: IDENTIFIED THE ORDERS PER BELOW: BOX NUMBER 1 WAS SHIPPED ON 31-JUN-2024. BOX NUMBER 2 WAS SHIPPED ON 13-AUG-2024. THIS EVENT MEETS THE REQUIREMENTS FOR FDA REPORTABILITY; HOWEVER, SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, MANUFACTURER OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20252630 ↗InjurySep 18, 2024Delivered as Unsterile Product; Delivered as Unsterile Product
THIS FOLLOW UP REPORT FOR MDR 9610877-2024-00094 SERVES AS A RETRACTION OF THE INITIAL REPORT INVALIDATING THE SEPTEMBER 18, 2024 INITIAL SUBMISSION. REFER TO H11 FOR ADDITIONAL DETAILS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20252629 ↗MalfunctionSep 18, 2024Delivered as Unsterile Product; Delivered as Unsterile Product
ON 30-AUG-2024, PENTAX MEDICAL BECAME AWARE OF OF AN INITIAL REPORT OF SHIPMENT OF THREE(3) EXPIRED BALLOON KITS RECEIVED AT THE USER FACILITY: #1- CONTAINING ONE(1) BOX WAS THAT WAS SHIPPED TO THE USER FACILITY ON 24-JUN-2024, WITH AN EXPIRATION DATE OF 30-JUN-2024. #2- CONTAINING TWO(2) BOXES THAT WERE SHIPPED TO THE USER FACILITY ON 14-AUG-2024 WITH THE SAME EXPIRATION DATE (30-JUN-2024). THERE WAS NO REPORT OF PATIENT HARM. DESCRIPTION OF ANY ACTIONS TAKEN: IDENTIFIED THE ORDERS PER BELOW: BOX NUMBER 1 WAS SHIPPED ON 31-JUN-2024. BOX NUMBER 2 WAS SHIPPED ON 13-AUG-2024. THIS EVENT MEETS THE REQUIREMENTS FOR FDA REPORTABILITY; HOWEVER, SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, MANUFACTURER OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT..
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20252628 ↗MalfunctionSep 18, 2024Delivered as Unsterile Product; Delivered as Unsterile Product
ON 30-AUG-2024, PENTAX MEDICAL BECAME AWARE OF OF AN INITIAL REPORT OF SHIPMENT OF THREE(3) EXPIRED BALLOON KITS RECEIVED AT THE USER FACILITY: #1- CONTAINING ONE(1) BOX WAS THAT WAS SHIPPED TO THE USER FACILITY ON 24-JUN-2024, WITH AN EXPIRATION DATE OF 30-JUN-2024. #2- CONTAINING TWO(2) BOXES THAT WERE SHIPPED TO THE USER FACILITY ON 14-AUG-2024 WITH THE SAME EXPIRATION DATE (30-JUN-2024). THERE WAS NO REPORT OF PATIENT HARM. DESCRIPTION OF ANY ACTIONS TAKEN: IDENTIFIED THE ORDERS PER BELOW: BOX NUMBER 1 WAS SHIPPED ON 31-JUN-2024. BOX NUMBER 2 WAS SHIPPED ON 13-AUG-2024. THIS EVENT MEETS THE REQUIREMENTS FOR FDA REPORTABILITY; HOWEVER, SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, MANUFACTURER OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT..
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20252627 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.