<PAGE> 1
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): July 30, 1996
TARGET THERAPEUTICS, INC.
- --------------------------------------------------------------------------------
(Exact name of registrant as specified in its charter)
Delaware
- --------------------------------------------------------------------------------
(State or other jurisdiction of incorporation)
0-19801 95-3962471
- --------------------------------------------------------------------------------
(Commission File Number) (IRS Employer Identification No.)
47201 Lakeview Blvd., Fremont, CA 94538
- --------------------------------------------------------------------------------
(Address of principal executive offices) (Zip Code)
Registrant's telephone number, including area code: (510) 440-7700
--------------------------
N/A
- --------------------------------------------------------------------------------
(Former name or former address, if changed since last report)
<PAGE> 2
ITEM 5. OTHER EVENTS
On July 30, 1996, Target Therapeutics, Inc., a Delaware corporation
(the "Company"), announced a partial recall of certain lots of its Guglielmi
Detachable Coil products due to a potential problem related to difficulty in the
flouroscopic visualization of the marker on the delivery wires of these lots of
devices. Further details regarding this announcement are contained in the
Company's press release dated July 30, 1996 attached as an exhibit hereto and
incorporated by reference herein.
ITEM 7. FINANCIAL STATEMENTS, PRO FORMA FINANCIAL INFORMATION AND EXHIBITS.
(c) EXHIBITS.
Exhibit 21.1 Target Therapeutics, Inc. Press Release dated July 30,
1996.
- 2 -
<PAGE> 3
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934,
the Registrant has duly caused this report to be signed on its behalf by the
undersigned thereunto duly authorized.
TARGET THERAPEUTICS, INC.
(Registrant)
Dated: August 1, 1996 By: /s/ Robert E. McNamara
----------------------
Robert E. McNamara
Vice President, Finance and Administration,
Chief Financial Officer (Principal Financial and
Accounting Officer) and Assistant Secretary
- 3 -
<PAGE> 4
INDEX TO EXHIBITS
Exhibits
--------
21.1 Target Therapeutics, Inc. Press Release dated July 30, 1996.
<PAGE> 1
EXHIBIT 21.1
TARGET THERAPEUTICS ANNOUNCES PARTIAL RECALL
July 30,1996, 3:48 PM EDT
FREMONT, Calif., July 30 -- Target Therapeutics, Inc. (Nasdaq: TGET) today
announced that the company has initiated a partial recall of certain lots of the
Guglielmi Detachable Coil (GDC(R)) products due to a potential problem related
to difficulty in the fluoroscopic visualization of the marker on the delivery
wires of these lots of GDC(R) devices.
Gary Bang, president and CEO of Target Therapeutics stated, "The marker on the
affected delivery wires is not readily visible by fluoroscopy. While this has
not been associated with any reports of associated patient complications, we are
identifying and recovering any non-conforming products in our finished goods
inventory as well as in hospitals in the US and abroad. We have already notified
all GDC(R) accounts, including physicians and distributors, and we will replace
the non-conforming products as rapidly as possible. In addition, pending
completion of our swap-out program, we have notified all GDC(R) user physicians
requesting them to examine the GDC(R) device fluoroscopically for marker
visibility prior to using the device in a patient."
Target's preliminary investigation indicates that two lots of marker coil
sub-assemblies of the GDC(R) delivery wires were mistakenly made of surgical
stainless steel rather than platinum. The Tracker(R) 2-tip-marker catheter and
the GDC(R) coil itself, both of which are visible under fluoroscopy, are not
affected.
"We have commenced visiting our customer sites, and in the next several weeks
will swap out the affected inventory. We have developed a specific protocol for
examining and identifying the affected delivery wires. In carrying out this
process we want to minimize impact to our customers, keeping patient interests
at the top of our priorities, while complying with applicable laws and
regulations," said Mr. Bang.
Mr. Bang also said, "Our estimates indicate the problematic inventory is present
in a very small percentage of GDC(R) inventory in the hospital and supply
pipeline. The financial effect of this swap-out program may slightly compress
margins during the second quarter but should not materially affect our bottom
line."
Except for the historical information contained herein, the matters discussed in
this press release are forward looking statements, the, accuracy of which is
necessarily subject to risks and uncertainties. Initial stocking orders should
not be viewed as indicative of future results as repeat orders for the GDC will
be driven largely by the number of procedures performed by physicians. Actual
results may differ significantly from results discussed in the forward looking
statements. Actual results may be affected by, among other things, risks and
uncertainties related to new product development cycles, research and
development activities, regulatory approvals of new products, introduction of
competitive products by others, third party reimbursement, physician training,
and other factors set forth from time to time in the Company's Securities and
Exchange Commission filings including those factors set forth under the heading
"Factors That May Affect Future Results of Operations" in the Company's Form
10-K for the year ended March 31, 1996.
<PAGE> 2
Founded in 1985, Target Therapeutics, Inc. develops, manufactures and markets
specialized disposable micro-catheters, guidewires, micro-coils, silicone
balloons, embolics, and angioplasty products. These therapeutic devices are used
in minimally-invasive, procedures to reach disease, sites throughout the body
via the circulatory system. The Company's products allow highly targeted
treatment of diseased, ruptured or blocked vessels of the brain responsible for
stroke, as well as other disease sites in the body that are accessible through
small vessels of the circulatory system. The company's headquarters are in
Fremont, Calif.
