FDA Medical Device Recalls (openFDA)
Covidien Llc: TruClear Hysteroscopic Tissue Removal System Control Unit- designed to meet the requirements of intrauterine tissue removal. Model Number: 7209808
- Recall number
- Z-1467-2022
- Recalling firm
- Covidien Llc
- Product
- TruClear Hysteroscopic Tissue Removal System Control Unit- designed to meet the requirements of intrauterine tissue removal. Model Number: 7209808
- Status
- Open, Classified
- Initiated
- 2022-06-07
- Posted
- not on file
- Terminated
- not on file
- Reason
- Electrical component failure within the control unit. The observed failure mode is a loss of function of the device when used with handpiece and foot switch.
- Root cause
- Device Design
- Action
- Medtronic issued Urgent Medical Device Recall letter on 6/7/22 (Field Action #: FA1259) via UPS 2-day delivery. For outside U.S. countries, notifications are handled via a regionally approved method. Letter states reason for recall, health risk and action to take: "Identify and quarantine all affected product. The enclosed Customer Notification DetailReport includes affected product for your facility. " Return all affected product in your inventory to Medtronic. a. Product purchased directly from Medtronic: rs.covidienfeedbackcustomerservice@medtronic.com b. Product purchased through distributor: rs.gmbfcamitg@medtronic.com " Your local Medtronic Representative can assist you as necessary in initiating the return of this product. " Complete the enclosed Customer Confirmation Form and email it to rs.covidienfeedbackcustomerservice@medtronic.com " If you have questions or concerns regarding this recall, please contact Medtronic CustomerService at 800-854-3570.
- Quantity
- 33 units
- Distribution
- AZ CA CO IL KS MA MI MN MO NY OK PA TN TX TX WA Foreign: United Kingdom Ireland Netherlands Reunion Spain
- Lot, serial or model codes
- UDI-Device Identifier (GTIN/UPN) 10884521749931 Serial Number: YF1120, YF1126, YF1127, YF1128, YF1129, YF1130, YF1131, YF1133, YF1134, YF1135, YF1137, YF1138, YF1139, YF1140, YF1141, YF1142, YF1150, YF1152, YF1154, YF1156, YF1157, YF1158, YF1161, YF1163, YF1166, YF1167, YF1168, YF1169, YF1172, YF1175, YF1176, YF1177, YF1182
- 510(k) numbers
- ["K031787","K132015"]
- PMA numbers
- not on file
- Product code
- HIH
- Firm FEI
- 1282497
- Firm city
- Mansfield
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28