FLOW COUPLER Monitor Flow Coupler devices are sold in 5 sizes (2.0 mm, 2.5 mm, 3.0 mm, 3.5 mm, 4.0 mm). Implantable device for vascular use.
FDA Recall Z-0939-2021 · Posted None
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Recalling FirmBaxter Healthcare Corporation
Recall StatusOpen, Classified
Product CodeMVR
Date Initiated2020-12-28
Product Quantity109 units
Reason for Recall
Potential for the battery to lose its ability to be recharged.
Firm Action
Written notification letter titled, "Urgent Medical Device Recall" was sent to all consignees on 12/28/2020 via first class mail. The letter instructs the consignee to locate all affected devices at their facility; contact Synovis MCA to arrange for product return for the firmware upgrade, power button update, and battery replacement, if applicable; complete the enclosed Baxter customer reply form and return it to Baxter by e-mailing it to [email protected], even if the consignees does not have any inventory; and if the consignee distributes this product to other facilities or departments within their institution, to please forward a copy of this communication to them.
Root Cause
Software design
Distribution Pattern
Distributed nationwide to AZ, FL, OH, NY, GA, VA, MA, WI, MO, MT, WV, IL, NC, NJ, AR, CA, CO, CT, IA, ID, IN, KS, LA, MD, MI, MN, MS, NE, NH, NM, NV, OK, OR, PA, RI, WY, WA, VT, TX, TN, SC, SD
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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