FDA Medical Device Recalls Spike in 2014

2012-2014 FDA Medical Device Errors shows baseline increase in 2012,
Customed Spike in 2014 - ResearchAE.com

FDA Act Requires Recall Reporting

CFR - Code of Federal Regulations Title 21

Sec. 806.1 Scope.

(a) This part implements the provisions of section 519(f) of the Federal Food, Drug, and Cosmetic Act (the act) requiring device manufacturers and importers to report promptly to the Food and Drug Administration (FDA) certain actions concerning device corrections and removals, and to maintain records of all corrections and removals regardless of whether such corrections and removals are required to be reported to FDA. (b) The following actions are exempt from the reporting requirements of this part: (1) Actions taken by device manufacturers or importers to improve the performance or quality of a device but that do not reduce a risk to health posed by the device or remedy a violation of the act caused by the device. (2) Market withdrawals as defined in 806.2(h). (3) Routine servicing as defined in 806.2(k). (4) Stock recoveries as defined in 806.2(l). [62 FR 27191, May 19, 1997, as amended at 63 FR 42232, Aug. 7, 1998]

FDA Issues Final Medical Device Recalls Guidance - ca101614.pdf

FDA Law Blog: FDA’s Hollow Medical Device Recall Guidance: Ending Not with A Bang But A Whimper

Who recalls medical devices?

List of Device Recalls
In most cases, a company (manufacturer, distributor, or other responsible party) recalls a medical device on its own (voluntarily). When a company learns that it has a product that violates FDA law, it does two things:

• Recalls the device (through correction or removal)
• Notifies FDA.

Legally, FDA can require a company to recall a device. This could happen if a company refuses to recall a device that is associated with significant health problems or death. However, in practice, FDA has rarely needed to require a medical device recall.

FDA posts consumer information about the most serious medical device recalls. These products are on the list because there is a reasonable chance that they could cause serious health problems or death.

Use the yearly lists to find information about Class I medical device recalls and some Class II and III recalls of interest to consumers. The links give details about what to do if you own or use one of these products. If you wish to find a Class II or Class III recall, you can search the CDRH Recalls Database. 

Recent Medical Device Recalls

2014 Medical Device Recalls

7 Recent Medical Device Failures Catching FDA's Eye | EE Times

Trend Analysis 2003-2012

US FDA reports steep increase in medical device recalls thanks to improved incident reporting

A new report by the US Food and Drug Administration shows a 97% increase in recalls of medical devices between fiscal years 2003 and 2012 due to stepped up public safety efforts by both regulators and industry. The agency attributes its findings to improved incident reporting primarily among manufacturers of radiological devices and by firms previously cited for 21 CFR Part 806 observations.

In terms of raw numbers, US medical device recalls grew from 604 in 2003 to 1,190 in 2012. Numbers of recalls for Class I and II devices increased more or less steadily during that timeframe, according to FDA research; Class III device recall numbers showed more variance from year to year.

• Software-related issues most common recall cause
• Domestic manufacturers more likely to be recalled

Spinning results? 

Although the FDA and industry have touted the study results as proof of more effective incident monitoring and reporting, Emergo Group Vice President of Quality Consulting Richard Vincins argues that these numbers show how much more work needs to be done to better address recall issues. "I have observed over the years that as medical devices become more complex, manufacturers must implement proper design controls, design change management, verification testing, and validation testing to help them save valuable dollars on the bottom line and reduce regulatory oversight." 

Medical Device Recalls Nearly Doubled in a Decade - WSJ

Medical Device Recall Report FY 2003-2012 - UCM388442.pdf 

August 2014 Customed Massive Recall  Breaks Trend

Medical Device Manufacturers with more than 1 Class 1 Recall in 2014
Recalling Manufacturer	Recalls
Customed; Inc	233
Teleflex Medical	15
Nitinol Devices and Components; Inc.	12
Medline Industries; Inc.	11
ConMed Corporation	9
Smiths Medical ASD; Inc.	7
Richard-Allan Scientific Company	7
Covidien LLC	6
Hospira Inc.	5
Medtronic Neurosurgery	5
Thoratec Corporation	4
GE Healthcare; LLC	4
ICU Medical; Inc.	4
Abbott Diabetes Care; Inc.	2
Micro Therapeutics Inc; Dba Ev3 Neurovascular	2
Draeger Medical Systems; Inc.	2
Nellcor Puritan Bennett Inc. (dba Covidien LP)	2
Siemens Healthcare Diagnostics; Inc.	2
Synthes; Inc.	2
Codman & Shurtleff; Inc.	2
Baxter Healthcare Corp	2

Massive Recall of Medical Devices Largest Ever Recorded by FDA | RAPS

Posted 02 September 2014 By Alexander Gaffney, RAC

A massive medical device recall reported last week by the US Food and Drug Administration (FDA) is the largest-ever single-day event on record, according to data recently made available by FDA.

Background: Recall Trends

The devices, which were manufactured by Puerto Rico-based device manufacturer Customed, Inc, were given a Class I recall classification—FDA's most serious recall classification, given to those devices in cases where "there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death."

- See more at: http://www.raps.org/Regulatory-Focus/News/2014/09/02/20197/Massive-Recall-of-Medical-Devices-Largest-Ever-Recorded-by-FDA/#sthash.9mxgNA4L.dpuf

On 29 August 2014, FDA posted to its website 233 Class I recalls, all for devices manufactured by Customed.

From the voluntary recall notices posted to FDA's website, all of the devices were recalled for a single reason: Packaging flaws.

"Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots)," FDA explained in the notice. "This could result in an injury to the patient due to product contamination or loss of sterility condition."

In a warning to healthcare providers on 26 August 2014, FDA said that at least one of the devices was being recalled due to "adhesion" in the sterile packaging. "The defect could result in loss of product sterility and lead to infection."

Customed confirmed in a statement that all recalled devices were being recalled due to sterility concerns. No serious injuries or deaths have yet been reported to FDA, the agency said. The recall of the devices was reportedly initiated in June 2014 via an email and letter to all affected customers.

Several hundred thousand units are likely affected by the recall, according to data provided on FDA's website.

In addition to being the largest FDA recall on record, it is also most than 9 times larger than the previous largest Class I recall of devices—the 5 March 2014 recall of 28 devices—according to FDA data.

- See more at: http://www.raps.org/Regulatory-Focus/News/2014/09/02/20197/Massive-Recall-of-Medical-Devices-Largest-Ever-Recorded-by-FDA/#sthash.9mxgNA4L.dpuf

CUSTOMED Healing