Medtronic recalls PVAC GOLD catheters (990078) produced in past 18 months without updated instructions to reduce phrenic nerve injury risk during heart procedures.
The firm issued an updated instructions for use to reduce the potential for phrenic nerve injury.
Medtronic is recalling PVAC GOLD catheters used in heart procedures because outdated instructions could increase the risk of phrenic nerve injury. This is a safety update for medical devices used in atrial fibrillation treatments.
The catheter's outdated instructions could lead to improper placement during heart procedures, potentially causing injury to the phrenic nerve which controls breathing. This risk is specific to the catheter's use in atrial fibrillation treatments.
Patients undergoing cardiac ablation procedures for atrial fibrillation who use the recalled PVAC GOLD catheters. Medical professionals performing these procedures are most at risk.
Check for the model number 990078 on the catheter packaging. The recall affects all units distributed in the past 18 months without the updated instructions for use.
Verify if your catheter has the updated instructions for use (IFU) as the outdated version could increase phrenic nerve injury risk.
Medtronic issued updated instructions for use to reduce the potential for phrenic nerve injury during cardiac ablation procedures for atrial fibrillation.
The PVAC GOLD catheter model 990078 distributed in the past 18 months without the updated instructions for use.
No, but you should check if your catheter has the updated instructions for use to reduce phrenic nerve injury risk.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-1069-2019 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1069-2019 from Medtronic. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
