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MicroBlate Flex
CREO MEDICAL LIMITED · Model 7-AB1-001 · UDI-DI 05060359560209
NEY
Prescription
10
510(k) clearances
1,798
Adverse events (45 deaths)
27
Recalls
40
Facilities
Description
The AB1 instrument, when used with the Creo Medical Electrosurgical System, is intended for use in coagulation (ablation) of soft tissue. Dimensions: 1.00 m long with a diameter of 2.00 mm
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-11-23 | Covidien, LLC | The product is labeled with the incorrect expiration date. |
| 2021-09-29 | Covidien Llc | The firm identified an error in the device temperature monitoring circuitry which is designed to interrupt energy delivery in the event of a primary cooling system failure. Use of |
| 2021-07-20 | Angiodynamics, Inc. | Specific serial numbers of the Solero MTA Generator require servicing to upgrade the software to help reduce the incidence of Error 0001, which can occur during system start-up. |
| 2021-07-20 | Angiodynamics, Inc. | Specific serial numbers of the Solero MTA Generator require servicing to upgrade the software to help reduce the incidence of Error 0001, which can occur during system start-up. |
| 2021-07-20 | Angiodynamics, Inc. | Specific serial numbers of the Solero MTA Generator require servicing to upgrade the software to help reduce the incidence of Error 0001, which can occur during system start-up. |
| 2021-07-20 | Angiodynamics, Inc. | Specific serial numbers of the Solero MTA Generator require servicing to upgrade the software to help reduce the incidence of Error 0001, which can occur during system start-up. |
| 2019-04-17 | Angiodynamics Inc. (Navilyst Medical Inc.) | Updated Warning Statements in the Operator's Manual/Directions for Use and Software Updates to reduce the risk of potential patient harm due to a delay in performing a procedure |
| 2019-04-17 | Angiodynamics Inc. (Navilyst Medical Inc.) | Updated Warning Statements in the Operator's Manual/Directions for Use and Software Updates to reduce the risk of potential patient harm due to a delay in performing a procedure |
| 2019-04-17 | Angiodynamics Inc. (Navilyst Medical Inc.) | Updated Warning Statements in the Operator's Manual/Directions for Use and Software Updates to reduce the risk of potential patient harm due to a delay in performing a procedure |
| 2019-04-17 | Angiodynamics Inc. (Navilyst Medical Inc.) | Updated Warning Statements in the Operator's Manual/Directions for Use and Software Updates to reduce the risk of potential patient harm due to a delay in performing a procedure |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.