TruClear Hysteroscopic Tissue Removal Control Unit Electrical Failure
Covidien is recalling 33 TruClear Hysteroscopic Tissue Removal System Control Units due to electrical component failure causing loss of device function during surgery. The affected units were distributed to multiple U.S. states and foreign countries.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II device recall involving loss of function in a surgical instrument. Although no injuries or illnesses have been reported, the malfunction presents a risk of harm during active procedures. Per the severity rubric, risk-of-harm products where injury has not yet been reported receive a score of 3 (High).
Plain-English summary
Covidien LLC is recalling the TruClear Hysteroscopic Tissue Removal System Control Unit, Model 7209808. This device is used during hysteroscopic procedures to remove intrauterine tissue. The recall affects 33 units identified by specific serial numbers.
The control units contain an electrical component that can fail, resulting in complete loss of device function when used with the handpiece and foot switch. This malfunction could occur during an active surgical procedure, preventing the device from operating.
The affected units were distributed to healthcare facilities in Arizona, California, Colorado, Illinois, Kansas, Massachusetts, Michigan, Minnesota, Missouri, New York, Oklahoma, Pennsylvania, Tennessee, Texas, Washington, and internationally to the United Kingdom, Ireland, Netherlands, Reunion, and Spain. Healthcare providers should identify affected devices by their serial numbers and contact Covidien for replacement or further instructions.
The recalled product
- Product
- TruClear Hysteroscopic Tissue Removal System Control Unit- designed to meet the requirements of intrauterine tissue removal. Model Number: 7209808
- Manufacturer
- Covidien Llc
- Affected units
- 33
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
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