Maquet Servo-I Ventilator System -EDI CATHETER PHT Free… recallZ-1221-2019 · Getinge US Sales LLC · initiated Mar 20, 2019
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Getinge US Sales LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Edi Catheter labeled with wrong expiry date on single pack EDI catheter boxes
FDA root cause category: Under Investigation by firm
What the company is doing
Maquet issued letters to customers on March 20, 2019 via FedEx Standard Overnight states issue, health risk and action to take: remove product and contact Getinge Customer Service at 1-888-627-8383 (press option 2, then option 3) to request a return authorization (RMA) and shipping instructions to return any affected product. Questions please contact your Getinge representative or call the Getinge Customer Support at 1-888-627-8383 (press option 2, then option 3), Monday through Friday from 6:00 a.m. and 5:00 p.m. PST.
Recall details
- Recall number
- Z-1221-2019
- Status
- Terminated
- Initiated by the company
- Mar 20, 2019
- Recalling firm
- Getinge US Sales LLC
- Quantity
- 17 boxes (5 catheters per box)
- Product code
- PIF
- FDA submissions
- K153688
- Distribution
- Worldwide distribution - US nationwide in the states of FL, NC and countries of AT, FR, HC, PO.
Product description
Maquet Servo-I Ventilator System -EDI CATHETER PHT Free 6Fr/49cm 5/pkg Product Code/REF Number: 6685775 Product Usage: The Edi Catheter is a single-use naso-gastric feeding tube with an electrode array of ten electrodes. The Edi Catheter is intended for: - Detecting diaphragmatic electrical activity, (Edi signals) by which the two ventilator modes NAVA and NIV NAVA can be controlled. - Detecting diaphragmatic electrical activity, (Edi signals) by which the respiratory drive from the brain can be monitored. - administrating nutrition, fluids and medications by the naso-gastricenteric route.
Code information (models, lots, serial numbers)
Lot Number: 92265355 UDI Code: 6685775: 07325710002100
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Edi Cath. 6Fr/49cm 1/pkg 6686400Maquet Critical Care AB · Ventilator, Continuous, Facility Use1 recall0 reports
Other devices under the same FDA submission
4 devices cleared under K153688 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- Edi Catheter ENFit 6Fr/49 cm, 5pcs 6883898Maquet Critical Care AB · Gastrointestinal Tubes With Enteral Specific Connectors14 reports
- Edi Catheter ENFit 12Fr/125 cm, 5pcs 6883903Maquet Critical Care AB · Gastrointestinal Tubes With Enteral Specific Connectors4 reports
- Edi Catheter ENFit 8Fr/50 cm, 5pcs 6883900Maquet Critical Care AB · Gastrointestinal Tubes With Enteral Specific Connectors2 reports
- Edi Catheter ENFit 8Fr/100 cm, 5pcs 6883901Maquet Critical Care AB · Gastrointestinal Tubes With Enteral Specific Connectors1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page