CLASS II Device recall · Reported 27 Jul 2016 · FDA Enforcement Report

Angiographic Injector and Syringe recalled by Bayer Healthcare

Bayer Healthcare is recalling Angiographic Injector and Syringe, Medrad MRXperion MR Injection System, Medrad MRXperion, distributed in New York. The recall was initiated on 9 Jun 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesCatalog numbers: MRXP 200 Serial numbers: 100009, 100011, 100019, 100020, 100022, 100026, 100027, 100028, 100036, 100047, 100065, 100066, 100069, 100074, 100075, 100085, 100090, 100091, 100096, 100097, 100098, 100099, 100100, 100101, 100103, 100104, 100106, 100107, 100108, 100109, 100110, 100111, 100112, 100113, 100114, 100118, 100119, 100129, 100152, 100155, 100161, 100166

Quantity recalled42 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2244-2016
FDA event ID: 74513
Recalling firm: Bayer Healthcare, Indianola, PA
Classification: Class II
Status: Terminated
Recall initiated: 9 Jun 2016
FDA classified: 19 Jul 2016
Reported: 27 Jul 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Heart & Vascular Devices

Timeline

9 Jun 2016	Recall initiated by company
19 Jul 2016	Classified by FDA	+40 days
27 Jul 2016	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Bayer Healthcare is initiating this recall due to complaints that were received from customer sites describing a 4205 error message when the injector is used with a 3T scanner.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

Angiographic Injector and Syringe, MEDRAD MRXperion MR Injection System, MEDRAD MRXperion Sterile Disposable MRI Kit Usage: The MEDRAD MRXperion MR Injection System is a syringe based fluid delivery system indicated for delivery of contrast media and saline during MR applications. It is intended to be used for the specific purpose of injecting intravenous MR contrast media and saline into the human vascular system for diagnostic studies in magnetic resonance imaging (MRI) applications with MRI scanners that have a magnetic field strength between 0.7 and 3.0 Tesla. Only trained healthcare professionals are intended to operate this device.

Where it was distributed

Worldwide and the US state of NEW YORK

New York

Questions about this recall

Is Angiographic Injector and Syringe, Medrad MRXperion MR Injection System, Medrad MRXperion recalled?

Yes. Bayer Healthcare recalled Angiographic Injector and Syringe, Medrad MRXperion MR Injection System, Medrad MRXperion on 9 Jun 2016. The recall is Class II and its status is Terminated. Recall number Z-2244-2016.

Why was it recalled?

Bayer Healthcare is initiating this recall due to complaints that were received from customer sites describing a 4205 error message when the injector is used with a 3T scanner.

Which lots are affected?

Catalog numbers: MRXP 200 Serial numbers: 100009, 100011, 100019, 100020, 100022, 100026, 100027, 100028, 100036, 100047, 100065, 100066, 100069, 100074, 100075, 100085, 100090, 100091, 100096, 100097, 100098, 100099, 100100, 100101, 100103, 100104, 100106, 100107, 100108, 100109, 100110, 100111, 100112, 100113, 100114, 100118, 100119, 100129, 100152, 100155, 100161, 100166

Where was it sold?

Worldwide and the US state of NEW YORK

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Bayer Healthcare

All 11

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15 Feb 2017Device	CLASS II	Medrad Intego PET Infusion System recalled by Bayer Healthcare	Bayer Healthcare	Particulate Matter	Nationwide
23 Nov 2016Device	CLASS II	PET Infusion Pump recalled by Bayer Healthcare	Bayer Healthcare	Other	Nationwide
14 Sep 2016Device	CLASS II	Certegra Workstation used in conjunction recalled by Bayer Healthcare	Bayer Healthcare	Other	Nationwide
20 Jan 2016Device	CLASS II	Medrad Source Administration Sets recalled by Bayer Healthcare	Bayer Healthcare	Other	Nationwide
23 Sep 2015Device	CLASS II	Angiographic Injector recalled by Bayer Healthcare	Bayer Healthcare	Device Malfunction	Nationwide

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